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:
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.
Biotechnology process technician
Pharmaceutical manufacturing technician
Pharmaceutical process technician
Process technician
Production technician
Science manufacturing technician
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.
| Duty | KSBs |
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Duty 1 Conduct handover responsibilities - receiving information from or providing information to other shifts or maintenance teams. |
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Duty 2 Maintain the work area (housekeeping) following safety, environmental and risk management systems. |
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Duty 3 Undertake quality assurance processes. |
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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. |
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Duty 5 Complete process documentation - digital or paper based. For example, process and production records, traceability records, and quality assurance records. |
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Duty 6 Conduct first line routine maintenance and testing of process and plant equipment. |
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Duty 7 Participate in continuous improvement activities. |
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Duty 8 Participate in risk assessment activities. For example, task risk assessments and manual handling assessments. |
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Duty 9 Support audits - internal or external. For example, supply information, demonstrate and explain task. |
| Duty | KSBs |
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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 |
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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 |
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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 |
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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 |
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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 |
| Duty | KSBs |
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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 |
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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 |
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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 |
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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 |
K1: Science process manufacturing sector awareness: range of products, manufacturing environments, types of customers.
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K2: Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement.
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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.
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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.
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K5: Health and safety management systems; key performance indicators (KPIs) and learning from incidents.
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K6: Environmental hazards that can arise from process. Hierarchy of control.
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K7: Environmental management systems standard. Environmental Protection Act. Environmental signage and notices.
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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.
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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).
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K10: Medicines and Healthcare products Regulatory Agency (MHRA): their role and requirements.
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K11: Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows.
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K12: Numerical approximations and unit conversion tables. Areas, volumes, and pressure and flow rates calculations. Statistical data.
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K13: Documentation requirements: documentation control, auditable records.
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K14: Requirements for a second person witness and second person checks.
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K15: How customer feedback can be used to assess quality performance. Purpose of audits. Non-conformance reports (NCR). Corrective Action Preventive Action (CAPA).
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K16: Principles of laboratory quality procedures: calibration requirements for quality control, representative sampling, and common methods of analysis.
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K17: Preventative and reliability maintenance practices.
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K18: Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors.
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K19: Problem solving and fault-finding techniques: root cause analysis, 5-Whys.
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K20: Continuous improvement (CI) systems and techniques.
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K21: Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR).
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K22: Verbal communication techniques.
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K23: Written communication techniques. Technical report writing techniques.
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K24: Principles of team working. Principles of equality, diversity, and inclusion in the workplace.
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K25: Planning, prioritising, and time management techniques.
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K26: Standard operating procedures (SOP) - what they are and why they are important.
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K27: Standard operating conditions (SOC) - what they are and why they are important.
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K28: Process control systems and their constituent components.
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K29: Quality standards. On-line and off-line quality control.
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K30: Requirements for shutting down and preparing for maintenance.
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K31: Main factors influencing quality assurance in biotechnology process industries.
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K32: Microbiology: classifications, characteristics. Sterility assurance.
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K33: Common contamination routes during biotechnology production.
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K34: The different types of cells that make up living organisms. The advantages and disadvantages of each cell type for commercial manufacturing.
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K35: Proteins: ammino acids, protein structures, and antibodies.
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K36: Molecular biology: DNA (deoxyribonucleic acid), RNA (ribonucleic acid), genetics, and methods of manipulation.
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K37: Chemistry and biochemistry: chemical bond types, acid and bases and conductivity.
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K38: Biotechnology processes: cell mass commercial manufacture, separation from the remaining cellular material, common methods of purification of product.
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K39: Immunology: diseases and body response and how these are used to create new medicines.
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K40: The thermal properties of solids, liquids, and gases.
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K41: The structure and properties of elements, mixtures, compounds.
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K42: Types of water and its use: cooling water, purified water, water for injection.
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K43: Purpose and operation of biotechnology equipment.
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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.
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K45: Conventions for drawings and graphical information.
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K46: Standard operating procedures (SOP) - what they are and why they are important.
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K47: Standard operating conditions (SOC) - what they are and why they are important.
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K48: Process control systems and their constituent components.
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K49: Start up and shut down procedures.
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K50: Main factors influencing quality assurance in pharmaceutical process industries.
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K51: Quality standards. On-line and off-line quality control.
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K52: Science in aseptic processing: microbiology, classifications and characteristics.
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K53: Sources, types and the impact of contamination.
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K54: Science in aseptic processing: chemistry principles.
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K55: Science in aseptic processing: biological principles.
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K56: Science in aseptic processing: anatomy and physiology.
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K57: Science in aseptic processing: pharmaceuticals and formulations, radio pharmacy and clinical pharmacy.
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K58: Aseptic manufacturing regulation and legislation; licensing regulations, Good Manufacturing Practice (GMP), Good Documentation Practise (GDP).
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K59: Manufactured products within a licensed aseptic environment; types, use, and classifications.
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K60: Manufactured products within a non-licensed aseptic environment; types, use, and classifications.
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K61: Materials within aseptic manufacturing; preparation, storage and stock management.
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K62: Pre and in-process checking within aseptic services.
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K63: Purpose and operation of aseptic pharmaceutical equipment.
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K64: Utilities on site purpose and interaction with equipment: alarms, facility monitoring systems, filters, heating, ventilation and air conditioning (HVAC), and electrical equipment.
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K65: Requirements for full equipment maintenance.
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S1: Review instructions or information to understand the task.
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S2: Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost.
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S3: Identify hazards and risks in the workplace and personal safety and mitigation measures.
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S4: Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance.
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S5: Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation.
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S6: Apply sustainability principles for example, minimising waste.
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S7: Segregate resources for reuse, recycling, and waste handling.
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S8: Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge.
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S9: Apply first line maintenance practices.
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S10: Store tools and equipment.
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S11: Conduct calculations for example, conversations, tare weight, charge weights, yield calculations.
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S12: Interpret data for example, process data, quality control and test procedure data.
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S13: Perform second person witness and second person checks for critical tasks.
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S14: Identify issues for example, defects, deviations, process variance, and maintenance requirements.
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S15: Apply problem solving and fault-finding techniques.
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S16: Escalate issues outside limits of responsibility.
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S17: Record or enter information - paper based or electronic.
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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.
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S19: Apply continuous improvement techniques. Make a suggestion for improvement.
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S20: Apply team working principles.
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S21: Communicate with others verbally for example, colleagues and stakeholders.
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S22: Produce written documents for example, handover notes or emails, non-conformances, design change requests.
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S23: Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities.
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S24: Apply standard operating procedures (SOPs).
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S25: Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation.
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S26: Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable.
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S27: Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic.
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S28: Operate biotechnology equipment for example, start-up, shut down, or cleaning mode.
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S29: Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time.
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S30: Check calibration and calibrate analytical equipment.
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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.
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S32: Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing.
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S33: Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding.
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S34: Conduct aseptic method for example, aseptic technique or aseptic sampling.
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S35: Interpret drawings and graphs.
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S36: Apply standard operating procedures (SOPs).
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S37: Select, check, and prepare raw (incoming) materials for aseptic process for example, weighing, measuring, conditioning, dissolving, and sanitisation.
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S38: Conduct pre-checks of hand tools, equipment and machinery for aseptic process including calibration record where applicable.
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S39: Operate aseptic process equipment for example, start-up and shut-down.
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S40: Set aseptic process parameters such as temperature, and pressure.
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S41: Conduct pre and in-process checks such as environmental monitoring.
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S42: Make adjustments to aseptic process parameters.
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S43: Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing.
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S44: Clean equipment and process areas in-between production to avoid cross-contamination.
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S45: Conduct volume checks.
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S46: Calibrate analytical equipment.
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B1: Prioritise health, safety, and environment.
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B2: Consider sustainability when using resources and carrying out processes.
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B3: Team-focus to meet work goals including support for equality, diversity and inclusion.
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B4: Take responsibility for the quality of their own work.
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B5: Take responsibility for the quality of their own work.
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B6: Respond and adapt to work demands.
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B7: Committed to continued professional development.
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English and maths qualifications must be completed in line with the apprenticeship funding rules.
This standard aligns with the following professional recognition:
| Version | Change detail | Earliest start date | Latest start date |
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| 1.0 | Approved for delivery | 04/03/2024 | Not set |
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