Science manufacturing technician - Aseptic pharmaceuticals manufacturing technician

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

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

Process control systems and their constituent components.

Start up and shut down procedures.

Main factors influencing quality assurance in pharmaceutical process industries.

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

Science in aseptic processing: microbiology, classifications and characteristics.

Sources, types and the impact of contamination.

Science in aseptic processing: chemistry principles.

Science in aseptic processing: biological principles.

Science in aseptic processing: anatomy and physiology.

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

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

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

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

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

Pre and in-process checking within aseptic services.

Purpose and operation of aseptic pharmaceutical equipment.

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

Requirements for full equipment maintenance.

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

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

Process control systems and their constituent components.

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

Requirements for shutting down and preparing for maintenance.

Main factors influencing quality assurance in biotechnology process industries.

Microbiology: classifications, characteristics. Sterility assurance.

Common contamination routes during biotechnology production.

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

Proteins: ammino acids, protein structures, and antibodies.

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

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

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

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

The thermal properties of solids, liquids, and gases.

The structure and properties of elements, mixtures, compounds.

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

Purpose and operation of biotechnology equipment.

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.

Conventions for drawings and graphical information.

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

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

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.

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.

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

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

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

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.

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).

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

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

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

Documentation requirements: documentation control, auditable records.

Requirements for a second person witness and second person checks.

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

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

Preventative and reliability maintenance practices.

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

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

Continuous improvement (CI) systems and techniques.

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

Verbal communication techniques.

Written communication techniques. Technical report writing techniques.

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

Planning, prioritising, and time management techniques.

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

Apply standard operating procedures (SOPs).

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

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

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

Set aseptic process parameters such as temperature, and pressure.

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

Make adjustments to aseptic process parameters.

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

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

Conduct volume checks.

Calibrate analytical equipment.

Apply standard operating procedures (SOPs).

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

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

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

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

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

Check calibration and calibrate analytical equipment.

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

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

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

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

Interpret drawings and graphs.

Review instructions or information to understand the task.

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

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

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

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

Apply sustainability principles for example, minimising waste.

Segregate resources for reuse, recycling, and waste handling.

Apply first line maintenance practices.

Store tools and equipment.

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

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

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

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

Apply problem solving and fault-finding techniques.

Escalate issues outside limits of responsibility.

Record or enter information - paper based or electronic.

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.

Apply continuous improvement techniques. Make a suggestion for improvement.

Apply team working principles.

Communicate with others verbally for example, colleagues and stakeholders.

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

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

Take responsibility for the quality of their own work.

Take responsibility for the quality of their own work.

Prioritise health, safety, and environment.

Consider sustainability when using resources and carrying out processes.

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

Respond and adapt to work demands.

Committed to continued professional development.