Science manufacturing technician 2023

Key information

  1. Status: Approved for delivery
  2. Reference: ST1406
  3. Version: 1.0
  4. Level: 3
  5. Typical duration to gateway: 36 months
  6. Typical EPA period: 3 months
  7. Maximum funding: £22000
  8. Route: Engineering and manufacturing
  9. Date updated: 04/03/2024
  10. Approved for delivery: 4 March 2024
  11. Lars code: 755
  12. EQA provider: Ofqual is the intended EQA provider
  13. Example progression routes:
  14. Review:

    After three years

Apprenticeship summary Occupational standard EPA plan

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Apprenticeship summary

Overview of the role

Apply a process or processes to create products to a specification.

Occupation summary

Science manufacturing technicians are found in the process manufacturing sector.

This is a core and options apprenticeship. An apprentice must complete the core and one option relevant to their occupation. The options are:

  • Option 1. Biotechnology manufacturing technician
  • Option 2. Aseptic pharmaceuticals manufacturing technician

Biotechnology manufacturing technicians produce biological products such as proteins, antibodies, and DNA. These may be used in pharmaceuticals, agricultural products, food and feed, detergents, paper, textiles, and biofuels. The final product may be solid or liquid and may be filled into small volume bottles or large bulk containers. Typically, batch processing is used. They may work in a controlled environment, such as laboratory or clean room, or production facilities. Biotechnology has an important role to play in helping to address many global problems, such as climate change. For example, synthetic biology is already contributing to the development of many biological systems producing drugs, chemicals, and fuels without using fossil fuels.

Aseptic pharmaceuticals manufacturing technicians are involved in the manufacture of pharmaceutical products - medicines or drugs. They may be involved in part or all of the process including active pharmaceutical ingredients (API) production and final formulation. APIs are the medical ingredient that goes into medicines. Formulations typically involves the blending of the API and other ingredients. Production may be continuous or batch. Technicians work in highly controlled process areas. This could be in large process plant or small rooms depending on the type of medicine being made and the stage of the process. Typically, they will work in a clean room where air particulates are controlled to stop potential contamination of the product.

Both biotechnology and aseptic pharmaceuticals manufacturing technicians run and maintain the process or processes in line with operational parameters. They conduct quality assurance, resolving or escalating any issues, and complete records. Maintaining workplace safety by following health, safety and environmental risk and management systems is a vital part of the role. They also take part in risk assessment and improvement activities, and support audits.

On a daily basis, they work with other members of the process team. They also have contact with people in other teams for example, laboratory, maintenance, process engineering, supply chain, and warehouse. They may also have contact with external people such as, customers, service providers, and regulators.

They must ensure that the process and products meet quality specifications and are produced to schedule. They must work to external manufacturing regulations to protect the process, product, plant and equipment, company employees, and the environment. They must also consider sustainability. They may need to wear specialist PPE to protect the product or themselves. This may include, safety glasses, chemical resistant gloves, suits and footwear, and breathing apparatus. They may work alone or part of a team. They work with minimal supervision, taking responsibility for the quality and accuracy of their work.

Typical job titles include:

Aseptic manufacturing technician Aseptic pharmaceuticals process technician Biotechnology manufacturing technician Green leaf Biotechnology process technician Green leaf Pharmaceutical manufacturing technician Pharmaceutical process technician Process technician Production technician Science manufacturing technician

Duties

  • Duty 1 Conduct handover responsibilities - receiving information from or providing information to other shifts or maintenance teams.
  • Duty 2 Maintain the work area (housekeeping) following safety, environmental and risk management systems.
  • Duty 3 Undertake quality assurance processes.
  • Duty 4 Resolve and report, or escalate, process, quality, health and safety, environment, and operating environment issues when operating out of normal parameters. For example, out of specification parameter.
  • Duty 5 Complete process documentation - digital or paper based. For example, process and production records, traceability records, and quality assurance records.
  • Duty 6 Conduct first line routine maintenance and testing of process and plant equipment.
  • Duty 7 Participate in continuous improvement activities.
  • Duty 8 Participate in risk assessment activities. For example, task risk assessments and manual handling assessments.
  • Duty 9 Support audits - internal or external. For example, supply information, demonstrate and explain task.
  • Duty 10 (Biotechnology manufacturing technician) Run and maintain biotechnology process, plant, and equipment in line with operational parameters. For example, temperature, pressure, pH, oxygen, and chemical and biological concentration.
  • Duty 11 (Biotechnology manufacturing technician) Conduct packaging of biotechnology intermediate or final processed product.
  • Duty 12 (Biotechnology manufacturing technician) Conduct biotechnology equipment fault finding activities. For example, contamination investigation, and cleaning of failed equipment.
  • Duty 13 (Biotechnology manufacturing technician) Prepare biotechnology plant for maintenance, overhaul, or decommissioning. For example, decontamination, cleaning, isolation, segregation, and signage access restriction.
  • Duty 14 (Biotechnology manufacturing technician) Establish new biotechnology equipment or new operating conditions.
  • Duty 15 (Aseptic pharmaceuticals manufacturing technician) Plan and run team working schedule to coincide with operational parameters, stakeholder requirements, and product limitations. For example, delivery time, maximised equipment set up and time, reduced product wastage, product expiration, and approvals.
  • Duty 16 (Aseptic pharmaceuticals manufacturing technician) Start and maintain aseptic manufacturing process and equipment in line with operational parameters.
  • Duty 17 (Aseptic pharmaceuticals manufacturing technician) Conduct packaging, and transfer or dispatch of processed products for different product types and dispatch methods, including quality assurance checks.
  • Duty 18 (Aseptic pharmaceuticals manufacturing technician) Conduct investigational activities. For example, room or operator environmental studies.

Apprenticeship summary

ST1406, science manufacturing technician 2023 level 3

This is a summary of the key things that you – the apprentice and your employer need to know about your end-point assessment (EPA). You and your employer should read the EPA plan for the full details. It has information on assessment method requirements, roles and responsibilities, and re-sits and re-takes.

What is an end-point assessment and why it happens

An EPA is an assessment at the end of your apprenticeship. It will assess you against the knowledge, skills, and behaviours (KSBs) in the occupational standard. Your training will cover the KSBs. The EPA is your opportunity to show an independent assessor how well you can carry out the occupation you have been trained for.

Your employer will choose an end-point assessment organisation (EPAO) to deliver the EPA. Your employer and training provider should tell you what to expect and how to prepare for your EPA.

The length of the training for this apprenticeship is typically 36 months. The EPA period is typically 3 months.

The overall grades available for this apprenticeship are:

  • fail
  • pass
  • merit
  • distinction

When you pass the EPA, you will be awarded your apprenticeship certificate.

EPA gateway

The EPA gateway is when the EPAO checks and confirms that you have met any requirements required before you start the EPA. You will only enter the gateway when your employer says you are ready.

The gateway requirements for your EPA are:

  • achieved English and mathematics qualifications in line with the apprenticeship funding rules
  • for the interview underpinned by a portfolio of evidence, you must submit a portfolio of evidence

Assessment methods


Observation with questions

You will be observed by an independent assessor completing your work. It will last at least 3 hours. They will ask you at least 5 questions.


Interview underpinned by a portfolio of evidence

You will have an interview with an independent assessor. It will last at least 60 minutes. They will ask you at least 8 questions. The questions will be about certain aspects of your occupation. You need to compile a portfolio of evidence before the EPA gateway. You can use it to help answer the questions.


Multiple-choice test

You will complete a multiple-choice test. It will be closed book, meaning you will not have access to any books or reference materials.
In the test you can have:

  • a scientific calculator

The test will have 40 multiple-choice questions. You will have 60 minutes to complete it.


The EPAO will confirm where and when each assessment method will take place.

Who to contact for help or more information

You should speak to your employer if you have a query that relates to your job.

You should speak to your training provider if you have any questions about your training or EPA before it starts.

You should receive detailed information and support from the EPAO before the EPA starts. You should speak to them if you have any questions about your EPA once it has started.


Reasonable adjustments

If you have a disability, a physical or mental health condition or other special considerations, you may be able to have a reasonable adjustment that takes this into account. You should speak to your employer, training provider and EPAO and ask them what support you can get. The EPAO will decide if an adjustment is appropriate.


Professional recognition

This apprenticeship aligns with The Science Council for Registered Science Technician. Upon successful completion of the apprenticeship and upon receipt of the apprenticeship certificate, individuals are eligible to apply for RSciTech through a shortened application route. Individuals also need to be a member of a professional body that is licensed by the Science Council to be awarded this status. Further information is on the Science Council’s website.

Please contact the professional body for more details.

This apprenticeship aligns with The Institution of Chemical Engineers (IChemE) for Engineering Technician (EngTech). Upon successful completion of the apprenticeship and receipt of the apprenticeship certificate, individuals are eligible to apply for EngTech through a shortened application route. It will need to confirm that the EngTech requirements have been met. Individuals also need to be a member of a professional body licensed by the Engineering Council to be awarded this status. Further information is on the IChemE’s website.

Please contact the professional body for more details.

Print occupational standard

Details of the occupational standard

Occupation summary

Science manufacturing technicians are found in the process manufacturing sector.

This is a core and options apprenticeship. An apprentice must complete the core and one option relevant to their occupation. The options are:

  • Option 1. Biotechnology manufacturing technician
  • Option 2. Aseptic pharmaceuticals manufacturing technician

Biotechnology manufacturing technicians produce biological products such as proteins, antibodies, and DNA. These may be used in pharmaceuticals, agricultural products, food and feed, detergents, paper, textiles, and biofuels. The final product may be solid or liquid and may be filled into small volume bottles or large bulk containers. Typically, batch processing is used. They may work in a controlled environment, such as laboratory or clean room, or production facilities. Biotechnology has an important role to play in helping to address many global problems, such as climate change. For example, synthetic biology is already contributing to the development of many biological systems producing drugs, chemicals, and fuels without using fossil fuels.

Aseptic pharmaceuticals manufacturing technicians are involved in the manufacture of pharmaceutical products - medicines or drugs. They may be involved in part or all of the process including active pharmaceutical ingredients (API) production and final formulation. APIs are the medical ingredient that goes into medicines. Formulations typically involves the blending of the API and other ingredients. Production may be continuous or batch. Technicians work in highly controlled process areas. This could be in large process plant or small rooms depending on the type of medicine being made and the stage of the process. Typically, they will work in a clean room where air particulates are controlled to stop potential contamination of the product.

Both biotechnology and aseptic pharmaceuticals manufacturing technicians run and maintain the process or processes in line with operational parameters. They conduct quality assurance, resolving or escalating any issues, and complete records. Maintaining workplace safety by following health, safety and environmental risk and management systems is a vital part of the role. They also take part in risk assessment and improvement activities, and support audits.

On a daily basis, they work with other members of the process team. They also have contact with people in other teams for example, laboratory, maintenance, process engineering, supply chain, and warehouse. They may also have contact with external people such as, customers, service providers, and regulators.

They must ensure that the process and products meet quality specifications and are produced to schedule. They must work to external manufacturing regulations to protect the process, product, plant and equipment, company employees, and the environment. They must also consider sustainability. They may need to wear specialist PPE to protect the product or themselves. This may include, safety glasses, chemical resistant gloves, suits and footwear, and breathing apparatus. They may work alone or part of a team. They work with minimal supervision, taking responsibility for the quality and accuracy of their work.

Typical job titles include:

Aseptic manufacturing technician Aseptic pharmaceuticals process technician Biotechnology manufacturing technician Green leaf Biotechnology process technician Green leaf Pharmaceutical manufacturing technician Pharmaceutical process technician Process technician Production technician Science manufacturing technician

Entry requirements

Employers will set their own entry requirements. Typically, they require applicants to have GCSE science grade C or 4. An employer may require applicants to have a health screening to ensure suitability for working in some work environments. 

Core occupation duties

Duty KSBs

Duty 1 Conduct handover responsibilities - receiving information from or providing information to other shifts or maintenance teams.

K1 K2 K9 K22 K23 K24 K25

S1 S2 S8 S12 S14 S17 S18 S20 S21 S22

B3

Duty 2 Maintain the work area (housekeeping) following safety, environmental and risk management systems.

K3 K4 K5 K6 K7 K8 K11

S3 S4 S5 S6 S7 S10

B1 B2

Duty 3 Undertake quality assurance processes.

K14 K15 K16

S8 S13

Duty 4 Resolve and report, or escalate, process, quality, health and safety, environment, and operating environment issues when operating out of normal parameters. For example, out of specification parameter.

K2 K3 K4 K6 K8 K9 K10 K12 K18 K19 K21 K22 K23 K24

S11 S12 S14 S15 S16 S18 S22

B6

Duty 5 Complete process documentation - digital or paper based. For example, process and production records, traceability records, and quality assurance records.

K13 K21 K23

S17 S18 S22

Duty 6 Conduct first line routine maintenance and testing of process and plant equipment.

K17

S9

Duty 7 Participate in continuous improvement activities.

K1 K4 K8 K20 K21 K22 K23 K24

S11 S12 S18 S19 S20 S21 S22 S23

B3 B7

Duty 8 Participate in risk assessment activities. For example, task risk assessments and manual handling assessments.

K21 K22 K23 K24

S3 S17 S18 S20 S21 S22

B3

Duty 9 Support audits - internal or external. For example, supply information, demonstrate and explain task.

K21 K22 K23 K24

S14 S16 S17 S18 S20 S21 S22

B3

Option duties

Biotechnology manufacturing technician duties

Duty KSBs

Duty 10 Run and maintain biotechnology process, plant, and equipment in line with operational parameters. For example, temperature, pressure, pH, oxygen, and chemical and biological concentration.

K26 K27 K28 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45

S24 S25 S26 S27 S28 S29 S30 S31 S32 S33 S34 S35

B4

Duty 11 Conduct packaging of biotechnology intermediate or final processed product.

K26 K27 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45

S24 S28 S32 S33 S35

B4

Duty 12 Conduct biotechnology equipment fault finding activities. For example, contamination investigation, and cleaning of failed equipment.

K26 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45

S24 S28 S30 S32 S33 S34 S35

B4

Duty 13 Prepare biotechnology plant for maintenance, overhaul, or decommissioning. For example, decontamination, cleaning, isolation, segregation, and signage access restriction.

K26 K30 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45

S24 S28 S33 S35

B4

Duty 14 Establish new biotechnology equipment or new operating conditions.

K26 K27 K28 K29 K31 K32 K33 K34 K35 K36 K37 K38 K39 K40 K41 K42 K43 K44 K45

S24 S28 S30 S31 S32 S33 S34 S35

B4

Aseptic pharmaceuticals manufacturing technician duties

Duty KSBs

Duty 15 Plan and run team working schedule to coincide with operational parameters, stakeholder requirements, and product limitations. For example, delivery time, maximised equipment set up and time, reduced product wastage, product expiration, and approvals.

K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K63 K65

S36

B5

Duty 16 Start and maintain aseptic manufacturing process and equipment in line with operational parameters.

K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K63 K64 K65

S36 S37 S38 S39 S40 S41 S42 S43 S44 S45 S46

B5

Duty 17 Conduct packaging, and transfer or dispatch of processed products for different product types and dispatch methods, including quality assurance checks.

K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K64 K65

S8 S36 S38 S45 S46

B5

Duty 18 Conduct investigational activities. For example, room or operator environmental studies.

K46 K47 K48 K49 K50 K51 K52 K53 K54 K55 K56 K57 K58 K59 K60 K61 K62 K64 K65

S36 S38 S39 S42 S45 S46

B5

KSBs

Knowledge

K1: Science process manufacturing sector awareness: range of products, manufacturing environments, types of customers. Back to Duty

K2: Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement. Back to Duty

K3: Health and safety regulations, standards, and guidance: Control of Substances Hazardous to Health (COSHH), Dangerous Substances and Explosive Atmospheres Regulations (DSEAR), Electrical safety and compliance, Fire safety, Health and Safety at Work Act – responsibilities, incident and near miss reporting and investigation, Lifting Operations and Lifting Equipment Regulations (LOLER), Legionella, Lone working, Management of health and safety at work, Manual handling, Noise regulation, Permits to work, Provision and Use of Work Equipment Regulations (PUWER), Safety signage and purpose, Slips trips and falls, The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR), Working in confined spaces, and Working at height. Back to Duty

K4: Science process manufacturing safety hazards – risks they pose and their management: temperature, pressure, and vapours. Risk assessment and safe systems of work. Personal Protective Equipment (PPE) requirements. Emergency procedures. Back to Duty

K5: Health and safety management systems; key performance indicators (KPIs) and learning from incidents. Back to Duty

K6: Environmental hazards that can arise from process. Hierarchy of control. Back to Duty

K7: Environmental management systems standard. Environmental Protection Act. Environmental signage and notices. Back to Duty

K8: Principles of sustainability and circular economy. Resource (energy, water, and waste) efficiency and reuse of materials. Principles of control and management of emissions and waste. Back to Duty

K9: Continuous and batch techniques. Production requirements: product specification, processing specification, rate of production. Material safety data sheet, product labelling and product codes; the importance of identifying non-conforming materials and products. Overall Equipment Effectiveness (OEE). Stock control. Current Good Manufacturing Practice (cGMP). Back to Duty

K10: Medicines and Healthcare products Regulatory Agency (MHRA): their role and requirements. Back to Duty

K11: Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows. Back to Duty

K12: Numerical approximations and unit conversion tables. Areas, volumes, and pressure and flow rates calculations. Statistical data. Back to Duty

K13: Documentation requirements: documentation control, auditable records. Back to Duty

K14: Requirements for a second person witness and second person checks. Back to Duty

K15: How customer feedback can be used to assess quality performance. Purpose of audits. Non-conformance reports (NCR). Corrective Action Preventive Action (CAPA). Back to Duty

K16: Principles of laboratory quality procedures: calibration requirements for quality control, representative sampling, and common methods of analysis. Back to Duty

K17: Preventative and reliability maintenance practices. Back to Duty

K18: Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors. Back to Duty

K19: Problem solving and fault-finding techniques: root cause analysis, 5-Whys. Back to Duty

K20: Continuous improvement (CI) systems and techniques. Back to Duty

K21: Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR). Back to Duty

K22: Verbal communication techniques. Back to Duty

K23: Written communication techniques. Technical report writing techniques. Back to Duty

K24: Principles of team working. Principles of equality, diversity, and inclusion in the workplace. Back to Duty

K25: Planning, prioritising, and time management techniques. Back to Duty

K26: Standard operating procedures (SOP) - what they are and why they are important. Back to Duty

K27: Standard operating conditions (SOC) - what they are and why they are important. Back to Duty

K28: Process control systems and their constituent components. Back to Duty

K29: Quality standards. On-line and off-line quality control. Back to Duty

K30: Requirements for shutting down and preparing for maintenance. Back to Duty

K31: Main factors influencing quality assurance in biotechnology process industries. Back to Duty

K32: Microbiology: classifications, characteristics. Sterility assurance. Back to Duty

K33: Common contamination routes during biotechnology production. Back to Duty

K34: The different types of cells that make up living organisms. The advantages and disadvantages of each cell type for commercial manufacturing. Back to Duty

K35: Proteins: ammino acids, protein structures, and antibodies. Back to Duty

K36: Molecular biology: DNA (deoxyribonucleic acid), RNA (ribonucleic acid), genetics, and methods of manipulation. Back to Duty

K37: Chemistry and biochemistry: chemical bond types, acid and bases and conductivity. Back to Duty

K38: Biotechnology processes: cell mass commercial manufacture, separation from the remaining cellular material, common methods of purification of product. Back to Duty

K39: Immunology: diseases and body response and how these are used to create new medicines. Back to Duty

K40: The thermal properties of solids, liquids, and gases. Back to Duty

K41: The structure and properties of elements, mixtures, compounds. Back to Duty

K42: Types of water and its use: cooling water, purified water, water for injection. Back to Duty

K43: Purpose and operation of biotechnology equipment. Back to Duty

K44: Utilities on site purpose and interaction with equipment: alarms, condensers, compressors, coolers, driers, electrical equipment, filters, heat exchange (heat transfer and fluid flow principles), heating services (steam generation and distribution principles), pipe work, plant control systems, pressure relief, process control instrumentation and their calibration requirements, pumps, reactors, receivers, vacuum pumps, and valves. Back to Duty

K45: Conventions for drawings and graphical information. Back to Duty

K46: Standard operating procedures (SOP) - what they are and why they are important. Back to Duty

K47: Standard operating conditions (SOC) - what they are and why they are important. Back to Duty

K48: Process control systems and their constituent components. Back to Duty

K49: Start up and shut down procedures. Back to Duty

K50: Main factors influencing quality assurance in pharmaceutical process industries. Back to Duty

K51: Quality standards. On-line and off-line quality control. Back to Duty

K52: Science in aseptic processing: microbiology, classifications and characteristics. Back to Duty

K53: Sources, types and the impact of contamination. Back to Duty

K54: Science in aseptic processing: chemistry principles. Back to Duty

K55: Science in aseptic processing: biological principles. Back to Duty

K56: Science in aseptic processing: anatomy and physiology. Back to Duty

K57: Science in aseptic processing: pharmaceuticals and formulations, radio pharmacy and clinical pharmacy. Back to Duty

K58: Aseptic manufacturing regulation and legislation; licensing regulations, Good Manufacturing Practice (GMP), Good Documentation Practise (GDP). Back to Duty

K59: Manufactured products within a licensed aseptic environment; types, use, and classifications. Back to Duty

K60: Manufactured products within a non-licensed aseptic environment; types, use, and classifications. Back to Duty

K61: Materials within aseptic manufacturing; preparation, storage and stock management. Back to Duty

K62: Pre and in-process checking within aseptic services. Back to Duty

K63: Purpose and operation of aseptic pharmaceutical equipment. Back to Duty

K64: Utilities on site purpose and interaction with equipment: alarms, facility monitoring systems, filters, heating, ventilation and air conditioning (HVAC), and electrical equipment. Back to Duty

K65: Requirements for full equipment maintenance. Back to Duty

Skills

S1: Review instructions or information to understand the task. Back to Duty

S2: Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost. Back to Duty

S3: Identify hazards and risks in the workplace and personal safety and mitigation measures. Back to Duty

S4: Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance. Back to Duty

S5: Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation. Back to Duty

S6: Apply sustainability principles for example, minimising waste. Back to Duty

S7: Segregate resources for reuse, recycling, and waste handling. Back to Duty

S8: Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge. Back to Duty

S9: Apply first line maintenance practices. Back to Duty

S10: Store tools and equipment. Back to Duty

S11: Conduct calculations for example, conversations, tare weight, charge weights, yield calculations. Back to Duty

S12: Interpret data for example, process data, quality control and test procedure data. Back to Duty

S13: Perform second person witness and second person checks for critical tasks. Back to Duty

S14: Identify issues for example, defects, deviations, process variance, and maintenance requirements. Back to Duty

S15: Apply problem solving and fault-finding techniques. Back to Duty

S16: Escalate issues outside limits of responsibility. Back to Duty

S17: Record or enter information - paper based or electronic. Back to Duty

S18: Use information and digital technology for example, management information systems, human machine interfaces, word processing, spreadsheet, email, virtual learning platforms, document sharing platforms. Comply with cyber security requirements and GDPR. Back to Duty

S19: Apply continuous improvement techniques. Make a suggestion for improvement. Back to Duty

S20: Apply team working principles. Back to Duty

S21: Communicate with others verbally for example, colleagues and stakeholders. Back to Duty

S22: Produce written documents for example, handover notes or emails, non-conformances, design change requests. Back to Duty

S23: Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities. Back to Duty

S24: Apply standard operating procedures (SOPs). Back to Duty

S25: Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation. Back to Duty

S26: Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable. Back to Duty

S27: Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic. Back to Duty

S28: Operate biotechnology equipment for example, start-up, shut down, or cleaning mode. Back to Duty

S29: Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time. Back to Duty

S30: Check calibration and calibrate analytical equipment. Back to Duty

S31: Conduct at point analysis of the product using laboratory techniques (bench top analysis) for example, pH, conductivity measurement, optical density measurements, and protein concertation. Back to Duty

S32: Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. Back to Duty

S33: Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding. Back to Duty

S34: Conduct aseptic method for example, aseptic technique or aseptic sampling. Back to Duty

S35: Interpret drawings and graphs. Back to Duty

S36: Apply standard operating procedures (SOPs). Back to Duty

S37: Select, check, and prepare raw (incoming) materials for aseptic process for example, weighing, measuring, conditioning, dissolving, and sanitisation. Back to Duty

S38: Conduct pre-checks of hand tools, equipment and machinery for aseptic process including calibration record where applicable. Back to Duty

S39: Operate aseptic process equipment for example, start-up and shut-down. Back to Duty

S40: Set aseptic process parameters such as temperature, and pressure. Back to Duty

S41: Conduct pre and in-process checks such as environmental monitoring. Back to Duty

S42: Make adjustments to aseptic process parameters. Back to Duty

S43: Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. Back to Duty

S44: Clean equipment and process areas in-between production to avoid cross-contamination. Back to Duty

S45: Conduct volume checks. Back to Duty

S46: Calibrate analytical equipment. Back to Duty

Behaviours

B1: Prioritise health, safety, and environment. Back to Duty

B2: Consider sustainability when using resources and carrying out processes. Back to Duty

B3: Team-focus to meet work goals including support for equality, diversity and inclusion. Back to Duty

B4: Take responsibility for the quality of their own work. Back to Duty

B5: Take responsibility for the quality of their own work. Back to Duty

B6: Respond and adapt to work demands. Back to Duty

B7: Committed to continued professional development. Back to Duty

Qualifications

English and Maths

Apprentices without level 2 English and maths will need to achieve this level prior to taking the End-Point Assessment. For those with an education, health and care plan or a legacy statement, the apprenticeship’s English and maths minimum requirement is Entry Level 3. A British Sign Language (BSL) qualification is an alternative to the English qualification for those whose primary language is BSL.

Professional recognition

This standard aligns with the following professional recognition:

  • The Science Council for Registered Science Technician. Upon successful completion of the apprenticeship and upon receipt of the apprenticeship certificate, individuals are eligible to apply for RSciTech through a shortened application route. Individuals also need to be a member of a professional body that is licensed by the Science Council to be awarded this status. Further information is on the Science Council’s website.
  • The Institution of Chemical Engineers (IChemE) for Engineering Technician (EngTech). Upon successful completion of the apprenticeship and receipt of the apprenticeship certificate, individuals are eligible to apply for EngTech through a shortened application route. It will need to confirm that the EngTech requirements have been met. Individuals also need to be a member of a professional body licensed by the Engineering Council to be awarded this status. Further information is on the IChemE’s website.
Print EPA plan

End-point assessment plan

V1.0

Introduction and overview

This document explains the requirements for end-point assessment (EPA) for the science manufacturing technician 2023 apprenticeship. End-point assessment organisations (EPAOs) must follow this when designing and delivering the EPA.

Science manufacturing technician 2023 apprentices, their employers and training providers should read this document.

This is a core and options apprenticeship. An apprentice must be trained and assessed against the core and one option. The options are:

  • Biotechnology manufacturing technician
  • Aseptic pharmaceuticals manufacturing technician

A full-time science manufacturing technician 2023 apprentice typically spends 36 months on-programme. The apprentice must spend at least 12 months on-programme and complete the required amount of off-the-job training in line with the apprenticeship funding rules.

The EPA should be completed within an EPA period lasting typically 3 months.

The apprentice must complete their training and meet the gateway requirements before starting their EPA. The EPA will assess occupational competence.

An approved EPAO must conduct the EPA for this apprenticeship. Employers must select an approved EPAO from the apprenticeship provider and assessment register (APAR).

This EPA has 3 assessment methods.

The grades available for each assessment method are below.

Assessment method 1 - observation with questions:

  • fail
  • pass
  • distinction

Assessment method 2 - interview underpinned by a portfolio of evidence:

  • fail
  • pass
  • distinction

Assessment method 3 - multiple-choice test:

  • fail
  • pass

The result from each assessment method is combined to decide the overall apprenticeship grade. The following grades are available for the apprenticeship:

  • fail
  • pass
  • merit
  • distinction

EPA summary table

On-programme - typically 36 months

The apprentice must:

  • complete training to develop the knowledge, skills and behaviours (KSBs) outlined in this apprenticeship’s standard
  • complete training towards English and mathematics qualifications in line with the apprenticeship funding rules

  • compile a portfolio of evidence
End-point assessment gateway

The apprentice’s employer must be content that the apprentice is occupationally competent.

The apprentice must:

  • confirm they are ready to take the EPA
  • have achieved English and mathematics qualifications in line with the apprenticeship funding rules

For the interview underpinned by a portfolio of evidence, the apprentice must submit a portfolio of evidence.

Gateway evidence must be submitted to the EPAO, along with any organisation specific policies and procedures requested by the EPAO.

End-point assessment - typically 3 months

The grades available for each assessment method are below

Observation with questions:

  • fail

  • pass

  • distinction

Interview underpinned by a portfolio of evidence:

  • fail

  • pass

  • distinction

Multiple-choice test:

  • fail

  • pass

Overall EPA and apprenticeship can be graded:

    • fail
    • pass
    • merit
    • distinction
Professional recognition

This apprenticeship aligns with:

  • The Science Council for Registered Science Technician. Upon successful completion of the apprenticeship and upon receipt of the apprenticeship certificate, individuals are eligible to apply for RSciTech through a shortened application route. Individuals also need to be a member of a professional body that is licensed by the Science Council to be awarded this status. Further information is on the Science Council’s website.

This apprenticeship aligns with:

  • The Institution of Chemical Engineers (IChemE) for Engineering Technician (EngTech). Upon successful completion of the apprenticeship and receipt of the apprenticeship certificate, individuals are eligible to apply for EngTech through a shortened application route. It will need to confirm that the EngTech requirements have been met. Individuals also need to be a member of a professional body licensed by the Engineering Council to be awarded this status. Further information is on the IChemE’s website.
Re-sits and re-takes
  • re-take and re-sit grade cap: pass
  • re-sit timeframe: typically 2 months
  • re-take timeframe: typically 4 months

Duration of end-point assessment period

The EPA is taken in the EPA period. The EPA period starts when the EPAO confirms the gateway requirements have been met and is typically 3 months.

The EPAO should confirm the gateway requirements have been met and start the EPA as quickly as possible.

EPA gateway

The apprentice’s employer must be content that the apprentice is occupationally competent. That is, they are deemed to be working at or above the level set out in the apprenticeship standard and ready to undertake the EPA. The employer may take advice from the apprentice's training provider, but the employer must make the decision. The apprentice will then enter the gateway.

The apprentice must meet the gateway requirements before starting their EPA.

They must:

  • confirm they are ready to take the EPA
  • have achieved English and mathematics qualifications in line with the apprenticeship funding rules

  • submit a portfolio of evidence for the interview underpinned by a portfolio of evidence

Portfolio of evidence requirements:

The apprentice must compile a portfolio of evidence during the on-programme period of the apprenticeship. It should only contain evidence related to the KSBs that will be assessed by this assessment method. It will typically contain 10 discrete pieces of evidence. Evidence must be mapped against the KSBs. Evidence may be used to demonstrate more than one KSB; a qualitative as opposed to quantitative approach is suggested.

Evidence sources may include:

  • workplace documentation and records, for example: process, quality assurance
  • workplace policies and procedures
  • witness statements
  • annotated photographs
  • video clips with a maximum total duration of 10 minutes; the apprentice must be in view and identifiable

This is not a definitive list; other evidence sources can be included.

The portfolio of evidence should not include reflective accounts or any methods of self-assessment. Any employer contributions should focus on direct observation of performance for example, witness statements rather than opinions. The evidence provided should be valid and attributable to the apprentice; the portfolio of evidence should contain a statement from the employer and apprentice confirming this.

The EPAO should not assess the portfolio of evidence directly as it underpins the interview. The independent assessor should review the portfolio of evidence to prepare questions for the interview. They are not required to provide feedback after this review.

Gateway evidence must be submitted to the EPAO, along with any organisation specific policies and procedures requested by the EPAO.

Order of assessment methods

The assessment methods can be delivered in any order.

The result of one assessment method does not need to be known before starting the next.

Observation with questions

Overview

In the observation with questions, an independent assessor observes the apprentice in their workplace and asks questions. The apprentice completes their day-to-day duties under normal working conditions. Simulation is not allowed. It gives the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method.

Rationale

This assessment method is being used because:

  • this is a practical role
  • it can assess KSBs holistically
  • it should give employers assurance about an apprentice’s competence as it takes place in a real work setting
  • the familiar environment should allow the apprentice to perform at their best
  • it is cost effective, tasks completed during the observation should contribute to workplace productivity and it makes use of the employer’s resources and equipment

Delivery

The observation with questions must be structured to give the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method to the highest available grade.

An independent assessor must conduct and assess the observation with questions.

The independent assessor must only observe one apprentice at a time to ensure quality and rigour. They must be as unobtrusive as possible.

The EPAO must give the apprentice 2 weeks' notice of the observation with questions.

The observation must take 3 hours.

The independent assessor can increase the time of the observation with questions by up to 10%. This time is to allow the apprentice to complete a task or respond to a question if necessary.

The apprentice may choose to end any assessment method early. The apprentice must be confident they have demonstrated competence against the assessment requirements for the assessment method. The independent assessor or EPAO must ensure the apprentice is fully aware of all assessment requirements. The independent assessor or EPAO cannot suggest or choose to end any assessment methods early (unless in an emergency). The EPAO is responsible for ensuring the apprentice understands the implications of ending an assessment early if they choose to do so. The independent assessor may suggest the assessment continues. The independent assessor must document the apprentice’s request to end any assessment early.

The observation may be split into discrete sections held on the same working day.

The EPAO must manage invigilation of the apprentice during the assessment, to maintain security of the EPA, in line with their malpractice policy. This includes breaks and moving between locations.

The independent assessor must explain to the apprentice the format and timescales of the observation with questions before it starts. This does not count towards the assessment time.

The independent assessor should observe the following during the observation:

Core

  • organise own work
  • maintain the work area
  • apply control room procedures
  • conduct first line routine maintenance
  • communicate with others
  • complete process documentation

Option 1. Biotechnology manufacturing technician

  • run and maintain biotechnology process
  • conduct biotechnology quality assurance

Option 2. Aseptic pharmaceuticals manufacturing technician

  • run and maintain aseptic pharmaceutical process
  • conduct aseptic pharmaceutical quality assurance

Activities may relate to the same process or product, or different processes or products.

These activities provide the apprentice with the opportunity to demonstrate the KSBs mapped to this assessment method.

The independent assessor must ask questions. Questioning can occur both during and after the observation.

The purpose of the questions is to assess the apprentice's level of competence against the grading descriptors.

The time for questioning is included in the overall assessment time. The independent assessor must ask at least 5 questions. To remain as unobtrusive as possible, the independent assessor should ask questions during natural stops between tasks and after completion of work rather than disrupting the apprentice’s flow. The independent assessor must use the questions from the EPAO’s question bank or create their own questions in line with the EPAO’s training. Follow-up questions are allowed where clarification is required.

The independent assessor must ask questions about KSBs that were not observed to gather assessment evidence. These questions are in addition to the above set number of questions for the observation with questions and should be kept to a minimum.

The independent assessor must make the grading decision. The independent assessor must assess the observation and responses to questions holistically when deciding the grade.

The independent assessor must keep accurate records of the assessment. They must record:

  • the KSBs observed
  • the apprentice’s answers to questions
  • the KSBs demonstrated in answers to questions
  • the grade achieved

Assessment location

The observation with questions must take place in the apprentice’s normal place of work for example, their employer’s premises or a customer’s premises. Equipment and resources needed for the observation must be provided by the employer and be in good and safe working condition.

Questioning that occurs after the observation should take place in a suitable environment, for example a quiet room, free from distractions and influence.

Question and resource development

The EPAO must develop a purpose-built assessment specification and question bank. It is recommended this is done in consultation with employers of this occupation. The EPAO must maintain the security and confidentiality of EPA materials when consulting with employers. The assessment specification and question bank must be reviewed at least once a year to ensure they remain fit-for-purpose.  

The assessment specification must be relevant to the occupation and demonstrate how to assess the KSBs mapped to this assessment method. The EPAO must ensure that questions are refined and developed to a high standard. The questions must be unpredictable. A question bank of sufficient size will support this.

The EPAO must produce the following materials to support the observation with questions:

  • independent assessor assessment materials which include:
    • training materials
    • administration materials
    • moderation and standardisation materials
    • guidance materials
    • grading guidance
    • question bank
  • EPA guidance for the apprentice and the employer

The EPAO must ensure that the EPA materials are subject to quality assurance procedures including standardisation and moderation.

Interview underpinned by a portfolio of evidence

Overview

In the interview, an independent assessor asks the apprentice questions. It gives the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method.

The apprentice can refer to and illustrate their answers with evidence from their portfolio of evidence.

Rationale

This assessment method is being used because:

  • it assesses KSBs holistically and objectively
  • it allows for the assessment of KSBs that do not occur on a predictable or regular basis
  • it allows for the assessment of responses where there are a range of potential answers
  • it can be conducted remotely, potentially reducing cost

Delivery

The interview must be structured to give the apprentice the opportunity to demonstrate the KSBs mapped to this assessment method to the highest available grade.

An independent assessor must conduct and assess the interview.

The purpose of the independent assessor's questions is to assess the apprentice against the following themes:

Core

  • role and responsibilities
  • in process or post manufacturing procedures
  • sustainability
  • problem solving and fault finding
  • continuous improvement
  • written communication
  • information and digital technology
  • teamwork
  • continued professional development

Option 1. Biotechnology manufacturing technician

  • biotechnology process operations
  • shutting down and preparing for maintenance

Option 2. Aseptic pharmaceuticals manufacturing technician

  • maintenance requirements

The EPAO must give an apprentice 2 weeks' notice of the interview.

The independent assessor must have at least 2 weeks to review the supporting documentation.

The apprentice must have access to their portfolio of evidence during the interview.

The apprentice can refer to and illustrate their answers with evidence from their portfolio of evidence however, the portfolio of evidence is not directly assessed.

The interview must last for 60 minutes. The independent assessor can increase the time of the interview by up to 10%. This time is to allow the apprentice to respond to a question if necessary.

The apprentice may choose to end any assessment method early. The apprentice must be confident they have demonstrated competence against the assessment requirements for the assessment method. The independent assessor or EPAO must ensure the apprentice is fully aware of all assessment requirements. The independent assessor or EPAO cannot suggest or choose to end any assessment methods early (unless in an emergency). The EPAO is responsible for ensuring the apprentice understands the implications of ending an assessment early if they choose to do so. The independent assessor may suggest the assessment continues. The independent assessor must document the apprentice’s request to end any assessment early.

The independent assessor must ask at least 8 questions. The independent assessor must use the questions from the EPAO’s question bank or create their own questions in line with the EPAO’s training. Follow-up questions are allowed where clarification is required.

The independent assessor must make the grading decision.

The independent assessor must keep accurate records of the assessment. They must record:

  • the apprentice’s answers to questions
  • the KSBs demonstrated in answers to questions
  • the grade achieved 

Assessment location

The interview must take place in a suitable venue selected by the EPAO for example, the EPAO’s or employer’s premises.

The interview can be conducted by video conferencing. The EPAO must have processes in place to verify the identity of the apprentice and ensure the apprentice is not being aided.

The interview should take place in a quiet room, free from distractions and influence.

Question and resource development

The EPAO must develop a purpose-built assessment specification and question bank. It is recommended this is done in consultation with employers of this occupation. The EPAO must maintain the security and confidentiality of EPA materials when consulting with employers. The assessment specification and question bank must be reviewed at least once a year to ensure they remain fit-for-purpose.

The assessment specification must be relevant to the occupation and demonstrate how to assess the KSBs mapped to this assessment method. The EPAO must ensure that questions are refined and developed to a high standard. The questions must be unpredictable. A question bank of sufficient size will support this.

The EPAO must ensure that the apprentice has a different set of questions in the case of re-sits or re-takes.

The EPAO must produce the following materials to support the interview underpinned by a portfolio of evidence:

  • independent assessor assessment materials which include:
    • training materials
    • administration materials
    • moderation and standardisation materials
    • guidance materials
    • grading guidance
    • question bank
  • EPA guidance for the apprentice and the employer

The EPAO must ensure that the EPA materials are subject to quality assurance procedures including standardisation and moderation.

Multiple-choice test

Overview

In the multiple-choice test, the apprentice answers questions in a controlled and invigilated environment. It gives the apprentice the opportunity to demonstrate the knowledge mapped to this assessment method.

Rationale

This assessment method is being used because:

  • it can assess knowledge
  • it is easy to administer
  • it can be conducted remotely and administered to multiple apprentices at the same time, potentially reducing cost

Delivery


The multiple-choice test must be structured to give the apprentice the opportunity to demonstrate the knowledge mapped to this assessment method to the highest available grade.

The test can be computer or paper based.

The test will consist of 40 multiple-choice questions.

Multiple-choice questions must have four options, including one correct answer.

The apprentice must be given at least 2 weeks’ notice of the date and time of the test.

Test administration

The apprentice must have 60 minutes to complete the test.

The test is closed book which means that the apprentice cannot refer to reference books or materials whilst taking the test.

The following equipment is allowed to be used during the test:

  • a scientific calculator

The test must be taken in the presence of an invigilator who is the responsibility of the EPAO. The EPAO must have an invigilation policy setting out how the test must be conducted. It must state the ratio of apprentices to invigilators for the setting and allow the test to take place in a secure way.

The EPAO must verify the apprentice’s identity and ensure invigilation of the apprentice for example, with 360-degree cameras and screen sharing facilities.

The EPAO is responsible for the security of the test including the arrangements for on-line testing. The EPAO must ensure that their security arrangements maintain the validity and reliability of the test.

Marking

The test must be marked by an independent assessor or marker employed by the EPAO. They must follow a marking scheme produced by the EPAO. Marking by computer is allowed where question types support this.

A correct answer gets 1 mark.

Any incorrect or missing answers get zero marks.

The EPAO is responsible for overseeing the marking of the test.

Assessment location

The apprentice must take the test in a suitably controlled and invigilated environment that is a quiet room, free from distractions and influence. The EPAO must check the venue is suitable.

The test could take place remotely if the appropriate technology and systems are in place to prevent malpractice.

Question and resource development

The EPAO must develop a purpose-built assessment specification and question bank. It is recommended this is done in consultation with employers of this occupation. The EPAO should maintain the security and confidentiality of EPA materials when consulting with employers. The assessment specification and question bank must be reviewed at least once a year to ensure they remain fit-for-purpose.    

The assessment specification must be relevant to the occupation and demonstrate how to assess the KSBs mapped to this assessment method. The EPAO must ensure that questions are refined and developed to a high standard. The questions must be unpredictable. A question bank of sufficient size will support this.  

The EPAO must ensure that the apprentice has a different set of questions in the case of re-sits or re-takes.

The EPAO must produce the following materials to support the test:

  • assessment materials for independent assessors and markers which includes:
    • training materials
    • administration materials
    • moderation and standardisation materials
    • guidance materials
    • grading guidance
    • test specification
    • sample test and mark schemes
    • live tests and mark schemes
    • question bank
  • EPA guidance for the apprentice and the employer

The EPAO must ensure that the EPA materials are subject to quality assurance procedures including standardisation and moderation.

Grading

Observation with questions

Fail - does not meet pass criteria

Theme
KSBs
Pass
The apprentice must demonstrate all of the pass descriptors for the core and their option
Distinction
The apprentice must demonstrate all of the pass and distinction descriptors for the core and their option
(Core) Organise own work
K25 S1 S2

Reviews instructions or information to understand the task's requirements. (S1)

Plans tasks and identifies and organises resources required to complete it using planning, prioritising, and time management techniques with consideration for safety, environmental impact, quality, and cost. (K25, S2)

The balance of safety, environmental impact, quality, and cost factors in their planning decisions is justified. (K25, S2)
(Core) Maintain the work area
K4 K6 S3 S4 S7 S10 B1

Identifies health and safety and environmental hazards and risks in the workplace, and personal safety and mitigation measures with consideration of hierarchy of control and emergency procedures.

Prioritises and applies health, safety, and environmental procedures in compliance with regulations, standards and guidance mitigating against risks including use of personal protective equipment.

(K4, K6, S3, S4, B1)

Segregates resources for reuse, recycling, and waste handling in line with company procedures. (S7)

Stores tools and equipment in line with company procedures. (S10)

Explains the importance of applying health, safety and environmental procedures in their work. (K4, K6, S4)
(Core) Apply control room procedures
K11 S5

Applies controlled environmental procedures in line with the need and requirements for clean rooms in manufacturing including protocols for entering, gowning, working in, exiting, and material flows. (K11, S5)

None
(Core) Conduct first line routine maintenance
K17 S9

Applies first line maintenance practices in line with their company's preventative and reliability maintenance practices. (K17, S9)

Explains the benefits of applying preventative and reliability maintenance practices. (K17, S9)
(Core) Communicate with others
K22 S21

Uses verbal communication techniques suitable for the context. (K22, S21)

None
(Core) Complete process documentation
K13 S17

Records or enters data for work tasks - paper based or electronic - in line with company procedures for documentation control and auditable records. (K13, S17)

None
(Biotechnology technician) Option 1. Run and maintain biotechnology process
K26 K27 K28 K43 S24 S25 S26 S27 S28 S29 S33

Selects, checks, and prepares raw materials for biotechnology process or processes in line with task requirements and standard operating procedures. 

Conducts pre-checks of hand tools, equipment, and machinery for biotechnology process or processes, including calibration record where applicable, required for task in line with standard operating procedures.

Connects service connections for biotechnology process or processes in line with task requirements and standard operating procedures.

Operates biotechnology equipment and sets and adjusts biotechnology process parameters using process control system and its constituent components to maintain standard operating conditions for the task in line with standard operating procedures.

Removes and replaces disposable components and checks functionality to ensure no equipment errors.

(K26, K27, K28, K43, S24, S25, S26, S27, S28, S29, S33)

Justifies their approach to running biotechnology process in terms of effectiveness or efficiencies of practice and the impact of their actions on others. (K26, S24)
(Biotechnology technician) Option 1. Conduct biotechnology quality assurance
K29 K31 S30 S31 S32 B4

Checks calibration and calibrates analytical equipment in line with standard operating procedures.

Takes responsibility for the quality of own work by conducting at point analysis of product using laboratory techniques (bench top analysis) and applying quality assurance procedures in line with quality standards and on-line and off-line quality control requirements that take account of the main factors influencing quality assurance in biotechnology process industries.

(K29, K31, S30, S31, S32, B4)

None
(Aseptic pharmaceutical technician) Option 2. Run and maintain aseptic pharmaceutical process
K46 K47 K48 K49 K63 S36 S37 S38 S39 S40 S42

Selects, checks, and prepares raw materials for aseptic process in line with task requirements and standard operating procedures.

Conducts pre-checks of hand tools, equipment, and machinery for aseptic process, including calibration record where applicable, required for task in line with standard operating procedures.

Operates aseptic process equipment and sets and adjusts aseptic process parameters using process control system and its constituent components to maintain standard operating conditions for the task in line with standard operating procedures and start up and shut down procedures.

(K46, K47, K48, K49, K63, S36, S37, S38, S39, S40, S42)

Justifies their approach to running aseptic process in terms of effectiveness or efficiencies of practice and  the impact of their actions on others. (K46, S36)
(Aseptic pharmaceutical technician) Option 2. Conduct aseptic pharmaceutical quality assurance
K50 K51 K62 S41 S43 S44 S45 S46 B5

Conducts pre and in-process checks in line with aseptic services checking requirements.

Takes responsibility for the quality of own work by applying quality assurance procedures in line with quality standards and on-line and off-line quality control requirements that take account of the main factors influencing quality assurance in pharmaceutical process industries.

Cleans equipment and process areas in-between production in line with standard operating procedures to avoid cross-contamination in line with company procedures.

Conducts volume checks in line with company procedures.

Calibrates analytical equipment in line with standard operating procedures.

K50, K51, K62, S41, S43, S44, S45, S46, B5)

None

Interview underpinned by a portfolio of evidence

Fail - does not meet pass criteria

Theme
KSBs
Pass
The apprentice must demonstrate all of the pass descriptors for the core and their option
Distinction
The apprentice must demonstrate all of the pass and distinction descriptors for the core and their option
(Core) Role and responsibilities
K2 K14 S13 S16 B6

Describes their role as a science manufacturing technician including their limits of responsibility, how they escalate issues, and how they respond and adapt to work demands in line with organisational requirements.

Outlines the impact of an operator’s competence on product quality.

Outlines change control requirements and why they are important.

(K2, S16, B6)

Describes how they perform second person witness and second person checks for critical tasks in line with company requirements. (K14, S13)

Explains the importance of applying second person witness and second person checks for critical tasks and aseptic techniques in production. (K14, S13)
(Core) In process or post manufacturing procedures
S8

Describes how they apply in process or post-process manufacturing procedures in line with task requirements. (S8)

 

None
(Core) Sustainability
K8 S6 B2

Describes how they consider and apply the principles of sustainability and the circular economy when using resources and carrying out processes including resource efficiency, reuse of materials, and recycling and control of emissions and waste. (K8, S6, B2)

Explains how they have supported the development or implementation of sustainability practice in the workplace beyond their role for example, through promoting good practice to others, identifying improvement to practice. (K6, S6, B2)
(Core) Problem solving and fault finding
K18 K19 S14 S15

Describes how they identify issues and apply problem solving and fault-finding techniques to establish the root cause of common faults in processing including flow, blockages, instrumentation failures, seals, and human factors. (K18, K19, S14, S15)

Assesses the value of specific fault-finding and problem solving techniques for different issues. (K18, K19, S14, S15)
(Core) Continuous improvement
K20 S19

Describes how they have applied continuous improvement (CI) techniques and a made a viable suggestion for improvement in their work to support CI systems. (K20, S19)

Justifies the potential impact of the improvement suggestion with consideration to benefits and any potential risks. (K20, S19)
(Core) Written communication
K23 S22

Describes how they apply written communication and report writing techniques to produce communications in their work suitable for context. (K23, S22)

None
(Core) Information and digital technology
K21 S18

Describes how they use information and digital technology in work tasks in compliance with cyber security requirements and GDPR. (K21, S18)

None
(Core) Teamwork
K24 S20 B3

Describes how they apply team working principles to meet work goals in line with their company's policy on equality, diversity, and inclusion. (K24, S20, B3)

Justifies how their team focus approach helped to achieve a positive outcome in a team activity. (K24, S20, B3)
(Core) Continued professional development
S23 B7

Describes the planned and unplanned learning and development activities they have carried out and recorded to meet personal development needs, showing a commitment to future CPD. (S23, B7)

None
(Biotechnology technician) Option 1. Biotechnology process operations
K33 S34

Describes how they conduct aseptic method in line with task requirements to avoid common contamination routes in line with standard operating procedures. (K33, S34)

None

 
(Biotechnology technician) Option 1. Shutting down and preparing for maintenance
K30

Explains their company's requirements for shutting down and preparing for maintenance. (K30)

None
(Aseptic pharmaceutical technician) Option 2. Requirements for maintenance
K65

Explains their company's requirements for full maintenance. (K65)

None

Multiple-choice test

Grade Minimum marks required Maximum marks required
Fail 0 27
Pass 28 40

Overall EPA grading

Performance in the EPA determines the overall grade of:

  • fail

  • pass

  • merit

  • distinction

An independent assessor must individually grade the observation with questions and interview underpinned by a portfolio of evidence in line with this EPA plan.

The EPAO must combine the individual assessment method grades to determine the overall EPA grade.

If the apprentice fails one assessment method or more, they will be awarded an overall fail.

To achieve an overall pass, the apprentice must achieve at least a pass in all the assessment methods. To achieve an overall EPA merit, the apprentice must achieve a distinction in one assessment method (observation with questions, or interview underpinned by a portfolio of evidence), and a pass in the other two assessment methods. To achieve an overall EPA distinction, the apprentice must achieve a distinction in the observation with questions, a distinction in the interview underpinned by a portfolio of evidence, and a pass in the multiple-choice test.

Grades from individual assessment methods must be combined in the following way to determine the grade of the EPA overall.

Observation with questions Interview underpinned by a portfolio of evidence Multiple-choice test Overall Grading
Any grade Any grade Fail Fail
Any grade Fail Any grade Fail
Fail Any grade Any grade Fail
Pass Pass Pass Pass
Distinction Pass Pass Merit
Pass Distinction Pass Merit
Distinction Distinction Pass Distinction

Re-sits and re-takes

If the apprentice fails one assessment method or more, they can take a re-sit or a re-take at their employer’s discretion. The apprentice’s employer needs to agree that a re-sit or re-take is appropriate. A re-sit does not need further learning, whereas a re-take does. The apprentice should have a supportive action plan to prepare for a re-sit or a re-take.

The employer and the EPAO should agree the timescale for a re-sit or re-take. A re-sit is typically taken within 2 months of the EPA outcome notification. The timescale for a re-take is dependent on how much re-training is required and is typically taken within 4 months of the EPA outcome notification.

Failed assessment methods must be re-sat or re-taken within a 6-month period from the EPA outcome notification, otherwise the entire EPA will need to be re-sat or re-taken in full.

Re-sits and re-takes are not offered to an apprentice wishing to move from pass to a higher grade.

The apprentice will get a maximum EPA grade of if pass they need to re-sit or re-take one or more assessment methods, unless the EPAO determines there are exceptional circumstances.

Roles and responsibilities

Roles Responsibilities

Apprentice

As a minimum, the apprentice should:

  • complete on-programme training to meet the KSBs as outlined in the apprenticeship standard for a minimum of 12 months
  • complete the required amount of off-the-job training specified by the apprenticeship funding rules and as arranged by the employer and training provider
  • understand the purpose and importance of EPA
  • prepare for and undertake the EPA including meeting all gateway requirements

Employer

As a minimum, the apprentice's employer must:

  • select the training provider 
  • work with the training provider to select the EPAO 
  • work with the training provider, where applicable, to support the apprentice in the workplace and to provide the opportunities for the apprentice to develop the KSBs
  • arrange and support off-the-job training to be undertaken by the apprentice 
  • decide when the apprentice is working at or above the apprenticeship standard and is ready for EPA
  • ensure the apprentice is prepared for the EPA
  • ensure that all supporting evidence required at the gateway is submitted in line with this EPA plan
  • confirm arrangements with the EPAO for the EPA in a timely manner, including who, when, where
  • provide the EPAO with access to any employer-specific documentation as required for example, company policies
  • ensure that the EPA is scheduled with the EPAO for a date and time which allows appropriate opportunity for the apprentice to meet the KSBs
  • ensure the apprentice is given sufficient time away from regular duties to prepare for, and complete the EPA
  • ensure that any required supervision during the EPA period, as stated within this EPA plan, is in place
  • ensure the apprentice has access to the resources used to fulfil their role and carry out the EPA for workplace based assessments
  • remain independent from the delivery of the EPA
  • pass the certificate to the apprentice upon receipt

EPAO

As a minimum, the EPAO must:

  • conform to the requirements of this EPA plan and deliver its requirements in a timely manner
  • conform to the requirements of the apprenticeship provider and assessment register
  • conform to the requirements of the external quality assurance provider (EQAP)
  • understand the apprenticeship including the occupational standard and EPA plan 
  • make all necessary contractual arrangements including agreeing the price of the EPA
  • develop and produce assessment materials including specifications and marking materials, for example mark schemes, practice materials, training material
  • maintain and apply a policy for the declaration and management of conflict of interests and independence. This must ensure, as a minimum, there is no personal benefit or detriment for those delivering the EPA or from the result of an assessment. It must cover:
    • apprentices
    • employers
    • independent assessors
    • any other roles involved in delivery or grading of the EPA
  • have quality assurance systems and procedures that ensure fair, reliable and consistent assessment and maintain records of internal quality assurance (IQA) activity for external quality assurance (EQA) purposes
  • appoint independent, competent, and suitably qualified assessors in line with the requirements of this EPA plan
  • appoint administrators, invigilators and any other roles where required to facilitate the EPA
  • deliver induction, initial and on-going training for all their independent assessors and any other roles involved in the delivery or grading of the EPA as specified within this EPA plan. This should include how to record the rationale and evidence for grading decisions where required 
  • conduct standardisation with all their independent assessors before allowing them to deliver an EPA, when the EPA is updated, and at least once a year 
  • conduct moderation across all of their independent assessors’ decisions once EPAs have started according to a sampling plan, with associated risk rating of independent assessors 
  • monitor the performance of all their independent assessors and provide additional training where necessary 
  • develop and provide assessment recording documentation to ensure a clear and auditable process is in place for providing assessment decisions and feedback to all relevant stakeholders 
  • use language in the development and delivery of the EPA that is appropriate to the level of the apprenticeship
  • arrange for the EPA to take place in a timely manner, in consultation with the employer
  • provide information, advice, and guidance documentation to enable apprentices, employers and training providers to prepare for the EPA
  • confirm the gateway requirements have been met before they start the EPA for an apprentice
  • arrange a suitable venue for the EPA
  • maintain the security of the EPA including, but not limited to, verifying the identity of the apprentice, invigilation and security of materials
  • where the EPA plan permits assessment away from the workplace, ensure that the apprentice has access to the required resources and liaise with the employer to agree this if necessary
  • confirm the overall grade awarded
  • maintain and apply a policy for conducting appeals

Independent assessor

As a minimum, an independent assessor must: 

  • be independent, with no conflict of interest with the apprentice, their employer or training provider, specifically, they must not receive a personal benefit or detriment from the result of the assessment
  • have, maintain and be able to evidence up-to-date knowledge and expertise of the occupation
  • have the competence to assess the EPA and meet the requirements of the IQA section of this EPA plan
  • understand the apprenticeship’s occupational standard and EPA plan
  • attend induction and standardisation events before they conduct an EPA for the first time, when the EPA is updated, and at least once a year
  • use language in the delivery of the EPA that is appropriate to the level of the apprenticeship
  • work with other personnel, where used, in the preparation and delivery of assessment methods
  • conduct the EPA to assess the apprentice against the KSBs and in line with the EPA plan
  • make final grading decisions in line with this EPA plan
  • record and report assessment outcome decisions
  • comply with the IQA requirements of the EPAO
  • comply with external quality assurance (EQA) requirements

Training provider

As a minimum, the training provider must: 

  • conform to the requirements of the apprenticeship provider and assessment register
  • ensure procedures are in place to mitigate against any conflict of interest
  • work with the employer and support the apprentice during the off-the-job training to provide the opportunities to develop the KSBs as outlined in the occupational standard
  • deliver training to the apprentice as outlined in their apprenticeship agreement
  • monitor the apprentice’s progress during any training provider led on-programme learning
  • ensure the apprentice is prepared for the EPA
  • work with the employer to select the EPAO 
  • advise the employer, upon request, on the apprentice’s readiness for EPA
  • ensure that all supporting evidence required at the gateway is submitted in line with this EPA plan
  • remain independent from the delivery of the EPA

Marker

As a minimum, the marker must:

  • attend induction training as directed by the EPAO 
  • have no direct connection or conflict of interest with the apprentice, their employer or training provider
  • mark test answers in line with the EPAO’s mark scheme and procedures 

Invigilator

As a minimum, the invigilator must: 

  • attend induction training as directed by the EPAO  
  • not invigilate an assessment, solely, if they have delivered the assessed content to the apprentice 
  • invigilate and supervise the apprentice during tests and in breaks during assessment methods to prevent malpractice in line with the EPAO’s invigilation procedures 

Reasonable adjustments

The EPAO must have reasonable adjustments arrangements for the EPA.

This should include:

  • how an apprentice qualifies for a reasonable adjustment
  • what reasonable adjustments may be made

Adjustments must maintain the validity, reliability and integrity of the EPA as outlined in this EPA plan.

Special considerations

The EPAO must have special consideration arrangements for the EPA.

This should include:

  • how an apprentice qualifies for a special consideration
  • what special considerations will be given

Special considerations must maintain the validity, reliability and integrity of the EPA as outlined in this EPA plan.

Internal quality assurance

Internal quality assurance refers to the strategies, policies and procedures that an EPAO must have in place to ensure valid, consistent and reliable EPA decisions.

EPAOs for this EPA must adhere to the requirements within the roles and responsibilities table.

They must also appoint independent assessors who:

  • have recent relevant experience of the occupation or sector to at least occupational level 3 gained in the last 3 years or significant experience of the occupation or sector

Value for money

Affordability of the EPA will be aided by using at least some of the following:

  • completing applicable assessment methods online, for example computer-based assessment
  • utilising digital remote platforms to conduct applicable assessment methods
  • assessing multiple apprentices simultaneously where the assessment method permits this
  • using the employer’s premises
  • conducting assessment methods on the same day

Professional recognition

This apprenticeship aligns with:

  • The Science Council for Registered Science Technician. Upon successful completion of the apprenticeship and upon receipt of the apprenticeship certificate, individuals are eligible to apply for RSciTech through a shortened application route. Individuals also need to be a member of a professional body that is licensed by the Science Council to be awarded this status. Further information is on the Science Council’s website.

This apprenticeship aligns with:

  • The Institution of Chemical Engineers (IChemE) for Engineering Technician (EngTech). Upon successful completion of the apprenticeship and receipt of the apprenticeship certificate, individuals are eligible to apply for EngTech through a shortened application route. It will need to confirm that the EngTech requirements have been met. Individuals also need to be a member of a professional body licensed by the Engineering Council to be awarded this status. Further information is on the IChemE’s website.

KSB mapping table

Knowledge Assessment methods
K1: Core.

Science process manufacturing sector awareness: range of products, manufacturing environments, types of customers.

Back to Grading 		Multiple-choice test
K2: Core.

Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement.

Back to Grading 		Interview underpinned by a portfolio of evidence
K3: Core.

Health and safety regulations, standards, and guidance: Control of Substances Hazardous to Health (COSHH), Dangerous Substances and Explosive Atmospheres Regulations (DSEAR), Electrical safety and compliance, Fire safety, Health and Safety at Work Act – responsibilities, incident and near miss reporting and investigation, Lifting Operations and Lifting Equipment Regulations (LOLER), Legionella, Lone working, Management of health and safety at work, Manual handling, Noise regulation, Permits to work, Provision and Use of Work Equipment Regulations (PUWER), Safety signage and purpose, Slips trips and falls, The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR), Working in confined spaces, and Working at height.

Back to Grading 		Multiple-choice test
K4: Core.

Science process manufacturing safety hazards – risks they pose and their management: temperature, pressure, and vapours. Risk assessment and safe systems of work. Personal Protective Equipment (PPE) requirements. Emergency procedures.

Back to Grading 		Observation with questions
K5: Core.

Health and safety management systems; key performance indicators (KPIs) and learning from incidents.

Back to Grading 		Multiple-choice test
K6: Core.

Environmental hazards that can arise from process. Hierarchy of control.

Back to Grading 		Observation with questions
K7: Core.

Environmental management systems standard. Environmental Protection Act. Environmental signage and notices.

Back to Grading 		Multiple-choice test
K8: Core.

Principles of sustainability and circular economy. Resource (energy, water, and waste) efficiency and reuse of materials. Principles of control and management of emissions and waste.

Back to Grading 		Interview underpinned by a portfolio of evidence
K9: Core.

Continuous and batch techniques. Production requirements: product specification, processing specification, rate of production. Material safety data sheet, product labelling and product codes; the importance of identifying non-conforming materials and products. Overall Equipment Effectiveness (OEE). Stock control. Current Good Manufacturing Practice (cGMP).

Back to Grading 		Multiple-choice test
K10: Core.

Medicines and Healthcare products Regulatory Agency (MHRA): their role and requirements.

Back to Grading 		Multiple-choice test
K11: Core.

Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows.

Back to Grading 		Observation with questions
K12: Core.

Numerical approximations and unit conversion tables. Areas, volumes, and pressure and flow rates calculations. Statistical data.

Back to Grading 		Multiple-choice test
K13: Core.

Documentation requirements: documentation control, auditable records.

Back to Grading 		Observation with questions
K14: Core.

Requirements for a second person witness and second person checks.

Back to Grading 		Interview underpinned by a portfolio of evidence
K15: Core.

How customer feedback can be used to assess quality performance. Purpose of audits. Non-conformance reports (NCR). Corrective Action Preventive Action (CAPA).

Back to Grading 		Multiple-choice test
K16: Core.

Principles of laboratory quality procedures: calibration requirements for quality control, representative sampling, and common methods of analysis.

Back to Grading 		Multiple-choice test
K17: Core.

Preventative and reliability maintenance practices.

Back to Grading 		Observation with questions
K18: Core.

Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors.

Back to Grading 		Interview underpinned by a portfolio of evidence
K19: Core.

Problem solving and fault-finding techniques: root cause analysis, 5-Whys.

Back to Grading 		Interview underpinned by a portfolio of evidence
K20: Core.

Continuous improvement (CI) systems and techniques.

Back to Grading 		Interview underpinned by a portfolio of evidence
K21: Core.

Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR).

Back to Grading 		Interview underpinned by a portfolio of evidence
K22: Core.

Verbal communication techniques.

Back to Grading 		Observation with questions
K23: Core.

Written communication techniques. Technical report writing techniques.

Back to Grading 		Interview underpinned by a portfolio of evidence
K24: Core.

Principles of team working. Principles of equality, diversity, and inclusion in the workplace.

Back to Grading 		Interview underpinned by a portfolio of evidence
K25: Core.

Planning, prioritising, and time management techniques.

Back to Grading 		Observation with questions
K26: Biotechnology manufacturing technician.

Standard operating procedures (SOP) - what they are and why they are important.

Back to Grading 		Observation with questions
K27: Biotechnology manufacturing technician.

Standard operating conditions (SOC) - what they are and why they are important.

Back to Grading 		Observation with questions
K28: Biotechnology manufacturing technician.

Process control systems and their constituent components.

Back to Grading 		Observation with questions
K29: Biotechnology manufacturing technician.

Quality standards. On-line and off-line quality control.

Back to Grading 		Observation with questions
K30: Biotechnology manufacturing technician.

Requirements for shutting down and preparing for maintenance.

Back to Grading 		Interview underpinned by a portfolio of evidence
K31: Biotechnology manufacturing technician.

Main factors influencing quality assurance in biotechnology process industries.

Back to Grading 		Observation with questions
K32: Biotechnology manufacturing technician.

Microbiology: classifications, characteristics. Sterility assurance.

Back to Grading 		Multiple-choice test
K33: Biotechnology manufacturing technician.

Common contamination routes during biotechnology production.

Back to Grading 		Interview underpinned by a portfolio of evidence
K34: Biotechnology manufacturing technician.

The different types of cells that make up living organisms. The advantages and disadvantages of each cell type for commercial manufacturing.

Back to Grading 		Multiple-choice test
K35: Biotechnology manufacturing technician.

Proteins: ammino acids, protein structures, and antibodies.

Back to Grading 		Multiple-choice test
K36: Biotechnology manufacturing technician.

Molecular biology: DNA (deoxyribonucleic acid), RNA (ribonucleic acid), genetics, and methods of manipulation.

Back to Grading 		Multiple-choice test
K37: Biotechnology manufacturing technician.

Chemistry and biochemistry: chemical bond types, acid and bases and conductivity.

Back to Grading 		Multiple-choice test
K38: Biotechnology manufacturing technician.

Biotechnology processes: cell mass commercial manufacture, separation from the remaining cellular material, common methods of purification of product.

Back to Grading 		Multiple-choice test
K39: Biotechnology manufacturing technician.

Immunology: diseases and body response and how these are used to create new medicines.

Back to Grading 		Multiple-choice test
K40: Biotechnology manufacturing technician.

The thermal properties of solids, liquids, and gases.

Back to Grading 		Multiple-choice test
K41: Biotechnology manufacturing technician.

The structure and properties of elements, mixtures, compounds.

Back to Grading 		Multiple-choice test
K42: Biotechnology manufacturing technician.

Types of water and its use: cooling water, purified water, water for injection.

Back to Grading 		Multiple-choice test
K43: Biotechnology manufacturing technician.

Purpose and operation of biotechnology equipment.

Back to Grading 		Observation with questions
K44: Biotechnology manufacturing technician.

Utilities on site purpose and interaction with equipment: alarms, condensers, compressors, coolers, driers, electrical equipment, filters, heat exchange (heat transfer and fluid flow principles), heating services (steam generation and distribution principles), pipe work, plant control systems, pressure relief, process control instrumentation and their calibration requirements, pumps, reactors, receivers, vacuum pumps, and valves.

Back to Grading 		Multiple-choice test
K45: Biotechnology manufacturing technician.

Conventions for drawings and graphical information.

Back to Grading 		Multiple-choice test
K46: Aseptic pharmaceuticals manufacturing technician.

Standard operating procedures (SOP) - what they are and why they are important.

Back to Grading 		Observation with questions
K47: Aseptic pharmaceuticals manufacturing technician.

Standard operating conditions (SOC) - what they are and why they are important.

Back to Grading 		Observation with questions
K48: Aseptic pharmaceuticals manufacturing technician.

Process control systems and their constituent components.

Back to Grading 		Observation with questions
K49: Aseptic pharmaceuticals manufacturing technician.

Start up and shut down procedures.

Back to Grading 		Observation with questions
K50: Aseptic pharmaceuticals manufacturing technician.

Main factors influencing quality assurance in pharmaceutical process industries.

Back to Grading 		Observation with questions
K51: Aseptic pharmaceuticals manufacturing technician.

Quality standards. On-line and off-line quality control.

Back to Grading 		Observation with questions
K52: Aseptic pharmaceuticals manufacturing technician.

Science in aseptic processing: microbiology, classifications and characteristics.

Back to Grading 		Multiple-choice test
K53: Aseptic pharmaceuticals manufacturing technician.

Sources, types and the impact of contamination.

Back to Grading 		Multiple-choice test
K54: Aseptic pharmaceuticals manufacturing technician.

Science in aseptic processing: chemistry principles.

Back to Grading 		Multiple-choice test
K55: Aseptic pharmaceuticals manufacturing technician.

Science in aseptic processing: biological principles.

Back to Grading 		Multiple-choice test
K56: Aseptic pharmaceuticals manufacturing technician.

Science in aseptic processing: anatomy and physiology.

Back to Grading 		Multiple-choice test
K57: Aseptic pharmaceuticals manufacturing technician.

Science in aseptic processing: pharmaceuticals and formulations, radio pharmacy and clinical pharmacy.

Back to Grading 		Multiple-choice test
K58: Aseptic pharmaceuticals manufacturing technician.

Aseptic manufacturing regulation and legislation; licensing regulations, Good Manufacturing Practice (GMP), Good Documentation Practise (GDP).

Back to Grading 		Multiple-choice test
K59: Aseptic pharmaceuticals manufacturing technician.

Manufactured products within a licensed aseptic environment; types, use, and classifications.

Back to Grading 		Multiple-choice test
K60: Aseptic pharmaceuticals manufacturing technician.

Manufactured products within a non-licensed aseptic environment; types, use, and classifications.

Back to Grading 		Multiple-choice test
K61: Aseptic pharmaceuticals manufacturing technician.

Materials within aseptic manufacturing; preparation, storage and stock management.

Back to Grading 		Multiple-choice test
K62: Aseptic pharmaceuticals manufacturing technician.

Pre and in-process checking within aseptic services.

Back to Grading 		Observation with questions
K63: Aseptic pharmaceuticals manufacturing technician.

Purpose and operation of aseptic pharmaceutical equipment.

Back to Grading 		Observation with questions
K64: Aseptic pharmaceuticals manufacturing technician.

Utilities on site purpose and interaction with equipment: alarms, facility monitoring systems, filters, heating, ventilation and air conditioning (HVAC), and electrical equipment.

Back to Grading 		Multiple-choice test
K65: Aseptic pharmaceuticals manufacturing technician.

Requirements for full equipment maintenance.

Back to Grading 		Interview underpinned by a portfolio of evidence
Skill Assessment methods
S1: Core.

Review instructions or information to understand the task.

Back to Grading 		Observation with questions
S2: Core.

Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost.

Back to Grading 		Observation with questions
S3: Core.

Identify hazards and risks in the workplace and personal safety and mitigation measures.

Back to Grading 		Observation with questions
S4: Core.

Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance.

Back to Grading 		Observation with questions
S5: Core.

Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation.

Back to Grading 		Observation with questions
S6: Core.

Apply sustainability principles for example, minimising waste.

Back to Grading 		Interview underpinned by a portfolio of evidence
S7: Core.

Segregate resources for reuse, recycling, and waste handling.

Back to Grading 		Observation with questions
S8: Core.

Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge.

Back to Grading 		Interview underpinned by a portfolio of evidence
S9: Core.

Apply first line maintenance practices.

Back to Grading 		Observation with questions
S10: Core.

Store tools and equipment.

Back to Grading 		Observation with questions
S11: Core.

Conduct calculations for example, conversations, tare weight, charge weights, yield calculations.

Back to Grading 		Multiple-choice test
S12: Core.

Interpret data for example, process data, quality control and test procedure data.

Back to Grading 		Multiple-choice test
S13: Core.

Perform second person witness and second person checks for critical tasks.

Back to Grading 		Interview underpinned by a portfolio of evidence
S14: Core.

Identify issues for example, defects, deviations, process variance, and maintenance requirements.

Back to Grading 		Interview underpinned by a portfolio of evidence
S15: Core.

Apply problem solving and fault-finding techniques.

Back to Grading 		Interview underpinned by a portfolio of evidence
S16: Core.

Escalate issues outside limits of responsibility.

Back to Grading 		Interview underpinned by a portfolio of evidence
S17: Core.

Record or enter information - paper based or electronic.

Back to Grading 		Observation with questions
S18: Core.

Use information and digital technology for example, management information systems, human machine interfaces, word processing, spreadsheet, email, virtual learning platforms, document sharing platforms. Comply with cyber security requirements and GDPR.

Back to Grading 		Interview underpinned by a portfolio of evidence
S19: Core.

Apply continuous improvement techniques. Make a suggestion for improvement.

Back to Grading 		Interview underpinned by a portfolio of evidence
S20: Core.

Apply team working principles.

Back to Grading 		Interview underpinned by a portfolio of evidence
S21: Core.

Communicate with others verbally for example, colleagues and stakeholders.

Back to Grading 		Observation with questions
S22: Core.

Produce written documents for example, handover notes or emails, non-conformances, design change requests.

Back to Grading 		Interview underpinned by a portfolio of evidence
S23: Core.

Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities.

Back to Grading 		Interview underpinned by a portfolio of evidence
S24: Biotechnology manufacturing technician.

Apply standard operating procedures (SOPs).

Back to Grading 		Observation with questions
S25: Biotechnology manufacturing technician.

Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation.

Back to Grading 		Observation with questions
S26: Biotechnology manufacturing technician.

Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable.

Back to Grading 		Observation with questions
S27: Biotechnology manufacturing technician.

Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic.

Back to Grading 		Observation with questions
S28: Biotechnology manufacturing technician.

Operate biotechnology equipment for example, start-up, shut down, or cleaning mode.

Back to Grading 		Observation with questions
S29: Biotechnology manufacturing technician.

Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time.

Back to Grading 		Observation with questions
S30: Biotechnology manufacturing technician.

Check calibration and calibrate analytical equipment.

Back to Grading 		Observation with questions
S31: Biotechnology manufacturing technician.

Conduct at point analysis of the product using laboratory techniques (bench top analysis) for example, pH, conductivity measurement, optical density measurements, and protein concertation.

Back to Grading 		Observation with questions
S32: Biotechnology manufacturing technician.

Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing.

Back to Grading 		Observation with questions
S33: Biotechnology manufacturing technician.

Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding.

Back to Grading 		Observation with questions
S34: Biotechnology manufacturing technician.

Conduct aseptic method for example, aseptic technique or aseptic sampling.

Back to Grading 		Interview underpinned by a portfolio of evidence
S35: Biotechnology manufacturing technician.

Interpret drawings and graphs.

Back to Grading 		Multiple-choice test
S36: Aseptic pharmaceuticals manufacturing technician.

Apply standard operating procedures (SOPs).

Back to Grading 		Observation with questions
S37: Aseptic pharmaceuticals manufacturing technician.

Select, check, and prepare raw (incoming) materials for aseptic process for example, weighing, measuring, conditioning, dissolving, and sanitisation.

Back to Grading 		Observation with questions
S38: Aseptic pharmaceuticals manufacturing technician.

Conduct pre-checks of hand tools, equipment and machinery for aseptic process including calibration record where applicable.

Back to Grading 		Observation with questions
S39: Aseptic pharmaceuticals manufacturing technician.

Operate aseptic process equipment for example, start-up and shut-down.

Back to Grading 		Observation with questions
S40: Aseptic pharmaceuticals manufacturing technician.

Set aseptic process parameters such as temperature, and pressure.

Back to Grading 		Observation with questions
S41: Aseptic pharmaceuticals manufacturing technician.

Conduct pre and in-process checks such as environmental monitoring.

Back to Grading 		Observation with questions
S42: Aseptic pharmaceuticals manufacturing technician.

Make adjustments to aseptic process parameters.

Back to Grading 		Observation with questions
S43: Aseptic pharmaceuticals manufacturing technician.

Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing.

Back to Grading 		Observation with questions
S44: Aseptic pharmaceuticals manufacturing technician.

Clean equipment and process areas in-between production to avoid cross-contamination.

Back to Grading 		Observation with questions
S45: Aseptic pharmaceuticals manufacturing technician.

Conduct volume checks.

Back to Grading 		Observation with questions
S46: Aseptic pharmaceuticals manufacturing technician.

Calibrate analytical equipment.

Back to Grading 		Observation with questions
Behaviour Assessment methods
B1: Core.

Prioritise health, safety, and environment.

Back to Grading 		Observation with questions
B2: Core.

Consider sustainability when using resources and carrying out processes.

Back to Grading 		Interview underpinned by a portfolio of evidence
B3: Core.

Team-focus to meet work goals including support for equality, diversity and inclusion.

Back to Grading 		Interview underpinned by a portfolio of evidence
B4: Biotechnology manufacturing technician.

Take responsibility for the quality of their own work.

Back to Grading 		Observation with questions
B5: Aseptic pharmaceuticals manufacturing technician.

Take responsibility for the quality of their own work.

Back to Grading 		Observation with questions
B6: Core.

Respond and adapt to work demands.

Back to Grading 		Interview underpinned by a portfolio of evidence
B7: Core.

Committed to continued professional development.

Back to Grading 		Interview underpinned by a portfolio of evidence

Mapping of KSBs to grade themes

Observation with questions

KSBS GROUPED BY THEME Knowledge Skills Behaviour
(Core) Organise own work
K25
S1 S2

Planning, prioritising, and time management techniques. (K25)

Review instructions or information to understand the task. (S1)

Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost. (S2)

None
(Core) Maintain the work area
K4 K6
S3 S4 S7 S10
B1

Science process manufacturing safety hazards – risks they pose and their management: temperature, pressure, and vapours. Risk assessment and safe systems of work. Personal Protective Equipment (PPE) requirements. Emergency procedures. (K4)

Environmental hazards that can arise from process. Hierarchy of control. (K6)

Identify hazards and risks in the workplace and personal safety and mitigation measures. (S3)

Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance. (S4)

Segregate resources for reuse, recycling, and waste handling. (S7)

Store tools and equipment. (S10)

Prioritise health, safety, and environment. (B1)
(Core) Apply control room procedures
K11
S5

Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows. (K11)

Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation. (S5)

None
(Core) Conduct first line routine maintenance
K17
S9

Preventative and reliability maintenance practices. (K17)

Apply first line maintenance practices. (S9)

None
(Core) Communicate with others
K22
S21

Verbal communication techniques. (K22)

Communicate with others verbally for example, colleagues and stakeholders. (S21)

None
(Core) Complete process documentation
K13
S17

Documentation requirements: documentation control, auditable records. (K13)

Record or enter information - paper based or electronic. (S17)

None
(Biotechnology technician) Option 1. Run and maintain biotechnology process
K26 K27 K28 K43
S24 S25 S26 S27 S28 S29 S33

Standard operating procedures (SOP) - what they are and why they are important. (K26)

Standard operating conditions (SOC) - what they are and why they are important. (K27)

Process control systems and their constituent components. (K28)

Purpose and operation of biotechnology equipment. (K43)

Apply standard operating procedures (SOPs). (S24)

Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation. (S25)

Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable. (S26)

Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic. (S27)

Operate biotechnology equipment for example, start-up, shut down, or cleaning mode. (S28)

Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time. (S29)

Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding. (S33)

None
(Biotechnology technician) Option 1. Conduct biotechnology quality assurance
K29 K31
S30 S31 S32
B4

Quality standards. On-line and off-line quality control. (K29)

Main factors influencing quality assurance in biotechnology process industries. (K31)

Check calibration and calibrate analytical equipment. (S30)

Conduct at point analysis of the product using laboratory techniques (bench top analysis) for example, pH, conductivity measurement, optical density measurements, and protein concertation. (S31)

Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. (S32)

Take responsibility for the quality of their own work. (B4)
(Aseptic pharmaceutical technician) Option 2. Run and maintain aseptic pharmaceutical process
K46 K47 K48 K49 K63
S36 S37 S38 S39 S40 S42

Standard operating procedures (SOP) - what they are and why they are important. (K46)

Standard operating conditions (SOC) - what they are and why they are important. (K47)

Process control systems and their constituent components. (K48)

Start up and shut down procedures. (K49)

Purpose and operation of aseptic pharmaceutical equipment. (K63)

Apply standard operating procedures (SOPs). (S36)

Select, check, and prepare raw (incoming) materials for aseptic process for example, weighing, measuring, conditioning, dissolving, and sanitisation. (S37)

Conduct pre-checks of hand tools, equipment and machinery for aseptic process including calibration record where applicable. (S38)

Operate aseptic process equipment for example, start-up and shut-down. (S39)

Set aseptic process parameters such as temperature, and pressure. (S40)

Make adjustments to aseptic process parameters. (S42)

None
(Aseptic pharmaceutical technician) Option 2. Conduct aseptic pharmaceutical quality assurance
K50 K51 K62
S41 S43 S44 S45 S46
B5

Main factors influencing quality assurance in pharmaceutical process industries. (K50)

Quality standards. On-line and off-line quality control. (K51)

Pre and in-process checking within aseptic services. (K62)

Conduct pre and in-process checks such as environmental monitoring. (S41)

Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing. (S43)

Clean equipment and process areas in-between production to avoid cross-contamination. (S44)

Conduct volume checks. (S45)

Calibrate analytical equipment. (S46)

Take responsibility for the quality of their own work. (B5)

Interview underpinned by a portfolio of evidence

KSBS GROUPED BY THEME Knowledge Skills Behaviour
(Core) Role and responsibilities
K2 K14
S13 S16
B6

Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement. (K2)

Requirements for a second person witness and second person checks. (K14)

Perform second person witness and second person checks for critical tasks. (S13)

Escalate issues outside limits of responsibility. (S16)

Respond and adapt to work demands. (B6)
(Core) In process or post manufacturing procedures

S8

None

Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge. (S8)

None
(Core) Sustainability
K8
S6
B2

Principles of sustainability and circular economy. Resource (energy, water, and waste) efficiency and reuse of materials. Principles of control and management of emissions and waste. (K8)

Apply sustainability principles for example, minimising waste. (S6)

Consider sustainability when using resources and carrying out processes. (B2)
(Core) Problem solving and fault finding
K18 K19
S14 S15

Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors. (K18)

Problem solving and fault-finding techniques: root cause analysis, 5-Whys. (K19)

Identify issues for example, defects, deviations, process variance, and maintenance requirements. (S14)

Apply problem solving and fault-finding techniques. (S15)

None
(Core) Continuous improvement
K20
S19

Continuous improvement (CI) systems and techniques. (K20)

Apply continuous improvement techniques. Make a suggestion for improvement. (S19)

None
(Core) Written communication
K23
S22

Written communication techniques. Technical report writing techniques. (K23)

Produce written documents for example, handover notes or emails, non-conformances, design change requests. (S22)

None
(Core) Information and digital technology
K21
S18

Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR). (K21)

Use information and digital technology for example, management information systems, human machine interfaces, word processing, spreadsheet, email, virtual learning platforms, document sharing platforms. Comply with cyber security requirements and GDPR. (S18)

None
(Core) Teamwork
K24
S20
B3

Principles of team working. Principles of equality, diversity, and inclusion in the workplace. (K24)

Apply team working principles. (S20)

Team-focus to meet work goals including support for equality, diversity and inclusion. (B3)
(Core) Continued professional development

S23
B7

None

Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities. (S23)

Committed to continued professional development. (B7)
(Biotechnology technician) Option 1. Biotechnology process operations
K33
S34

Common contamination routes during biotechnology production. (K33)

Conduct aseptic method for example, aseptic technique or aseptic sampling. (S34)

None
(Biotechnology technician) Option 1. Shutting down and preparing for maintenance
K30

Requirements for shutting down and preparing for maintenance. (K30)

None

None
(Aseptic pharmaceutical technician) Option 2. Requirements for maintenance
K65

Requirements for full equipment maintenance. (K65)

None

None

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Employers involved in creating the standard: Fujifilm Diosynth Biotechnologies, Seqirus UK Limited, CPI, Seqens, York and Scarborough Teaching Hospitals NHS Foundation Trust, Leeds Teaching Hospitals NHS Trust

Version log

Version Change detail Earliest start date Latest start date Latest end date
1.0 Approved for delivery 04/03/2024 Not set Not set

Crown copyright © 2024. You may re-use this information (not including logos) free of charge in any format or medium, under the terms of the Open Government Licence. Visit www.nationalarchives.gov.uk/doc/open-government-licence

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