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Science manufacturing technician - Biotechnology manufacturing technician

Science manufacturing technician - Biotechnology manufacturing technician

Engineering and manufacturing

Level 3 - Technical Occupation

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

Reference: OCC1406B

Status: assignment_turned_inApproved occupation

Technical Education Products

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

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.

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

Typical job titles include:

Aseptic manufacturing technician
Aseptic pharmaceuticals process technician
Pharmaceutical manufacturing technician
Pharmaceutical process technician
Process technician
Production technician
Science manufacturing technician
Biotechnology manufacturing technicianeco
Biotechnology process technicianeco

Keywords:

Aseptic
Biotechnology
Formulated Products
Laboratory
Life Sciences
Manufacture
Primary And Secondary Pharmaceutical
Process
Processing
Science

Knowledge, skills and behaviours (KSBs)

K1: Science process manufacturing sector awareness: range of products, manufacturing environments, types of customers.
K2: Role and limits of responsibility. Escalation procedures. Impact of operators’ competence on product quality. Change control requirement.
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.
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.
K5: Health and safety management systems; key performance indicators (KPIs) and learning from incidents.
K6: Environmental hazards that can arise from process. Hierarchy of control.
K7: Environmental management systems standard. Environmental Protection Act. Environmental signage and notices.
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.
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).
K10: Medicines and Healthcare products Regulatory Agency (MHRA): their role and requirements.
K11: Need and requirements for clean rooms in manufacturing. Protocols for entering, gowning, working in, exiting, and material flows.
K12: Numerical approximations and unit conversion tables. Areas, volumes, and pressure and flow rates calculations. Statistical data.
K13: Documentation requirements: documentation control, auditable records.
K14: Requirements for a second person witness and second person checks.
K15: How customer feedback can be used to assess quality performance. Purpose of audits. Non-conformance reports (NCR). Corrective Action Preventive Action (CAPA).
K16: Principles of laboratory quality procedures: calibration requirements for quality control, representative sampling, and common methods of analysis.
K17: Preventative and reliability maintenance practices.
K18: Common faults and causes in processing: flow, blockages, instrumentation failures, seals and human factors.
K19: Problem solving and fault-finding techniques: root cause analysis, 5-Whys.
K20: Continuous improvement (CI) systems and techniques.
K21: Information and digital technology to support science manufacturing operations. Cyber security requirements. General data protection regulation (GDPR).
K22: Verbal communication techniques.
K23: Written communication techniques. Technical report writing techniques.
K24: Principles of team working. Principles of equality, diversity, and inclusion in the workplace.
K25: Planning, prioritising, and time management techniques.
K26: Standard operating procedures (SOP) - what they are and why they are important.
K27: Standard operating conditions (SOC) - what they are and why they are important.
K28: Process control systems and their constituent components.
K29: Quality standards. On-line and off-line quality control.
K30: Requirements for shutting down and preparing for maintenance.
K31: Main factors influencing quality assurance in biotechnology process industries.
K32: Microbiology: classifications, characteristics. Sterility assurance.
K33: Common contamination routes during biotechnology production.
K34: The different types of cells that make up living organisms. The advantages and disadvantages of each cell type for commercial manufacturing.
K35: Proteins: ammino acids, protein structures, and antibodies.
K36: Molecular biology: DNA (deoxyribonucleic acid), RNA (ribonucleic acid), genetics, and methods of manipulation.
K37: Chemistry and biochemistry: chemical bond types, acid and bases and conductivity.
K38: Biotechnology processes: cell mass commercial manufacture, separation from the remaining cellular material, common methods of purification of product.
K39: Immunology: diseases and body response and how these are used to create new medicines.
K40: The thermal properties of solids, liquids, and gases.
K41: The structure and properties of elements, mixtures, compounds.
K42: Types of water and its use: cooling water, purified water, water for injection.
K43: Purpose and operation of biotechnology equipment.
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.
K45: Conventions for drawings and graphical information.

S1: Review instructions or information to understand the task.
S2: Plan tasks. Identify and organise resources with consideration for safety, environmental impact, quality, and cost.
S3: Identify hazards and risks in the workplace and personal safety and mitigation measures.
S4: Apply health, safety, and environmental procedures in compliance with regulations, standards, and guidance.
S5: Apply controlled environment procedures for example, gowning, isolators, contamination control, and sanitisation.
S6: Apply sustainability principles for example, minimising waste.
S7: Segregate resources for reuse, recycling, and waste handling.
S8: Conduct in process or post-manufacturing procedure for example, labelling, packing, storage, visual inspection, discharge.
S9: Apply first line maintenance practices.
S10: Store tools and equipment.
S11: Conduct calculations for example, conversations, tare weight, charge weights, yield calculations.
S12: Interpret data for example, process data, quality control and test procedure data.
S13: Perform second person witness and second person checks for critical tasks.
S14: Identify issues for example, defects, deviations, process variance, and maintenance requirements.
S15: Apply problem solving and fault-finding techniques.
S16: Escalate issues outside limits of responsibility.
S17: Record or enter information - paper based or electronic.
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.
S19: Apply continuous improvement techniques. Make a suggestion for improvement.
S20: Apply team working principles.
S21: Communicate with others verbally for example, colleagues and stakeholders.
S22: Produce written documents for example, handover notes or emails, non-conformances, design change requests.
S23: Plan how to meet personal development needs. Carry out and record planned and unplanned learning and development activities.
S24: Apply standard operating procedures (SOPs).
S25: Select, check, and prepare raw materials for biotechnology process for example, weighing, measuring, control and blending, conditioning, dissolving, and sanitisation.
S26: Conduct pre-checks of hand tools, equipment and machinery for biotechnology process including calibration record where applicable.
S27: Connect service connections for biotechnology process such as water, electrical, pneumatic, hydraulic.
S28: Operate biotechnology equipment for example, start-up, shut down, or cleaning mode.
S29: Set and adjust biotechnology process parameters such as agitation revolutions per minute, temperature, pressure, flow rate or time.
S30: Check calibration and calibrate analytical equipment.
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.
S32: Apply quality assurance procedures. For example, conduct parameter checks (size, colour, weight), and take samples for laboratory testing.
S33: Remove and replace disposable components and check functionality for example, break lines, isolators, and tri-clamps and tube welding.
S34: Conduct aseptic method for example, aseptic technique or aseptic sampling.
S35: Interpret drawings and graphs.

B1: Prioritise health, safety, and environment.
B2: Consider sustainability when using resources and carrying out processes.
B3: Team-focus to meet work goals including support for equality, diversity and inclusion.
B4: Take responsibility for the quality of their own work.
B6: Respond and adapt to work demands.
B7: Committed to continued professional development.

Duties

Duty D1

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

Duty D2

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

Duty D3

Undertake quality assurance processes.

Duty D4

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 D5

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

Duty D6

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

Duty D7

Participate in continuous improvement activities.

Duty D8

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

Duty D9

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

Duty D10

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 D11

Conduct packaging of biotechnology intermediate or final processed product.

Duty D12

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

Duty D13

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

Duty D14

Establish new biotechnology equipment or new operating conditions.