Overview
Role responsibilities cover aseptic manufacturing activities, quality control, compliance and related process improvement tasks in a GMP environment.
Responsibilities
* Set up raw materials, containers, and equipment required for aseptic manufacturing, following GMP documentation and customer priorities
* Perform routine and thorough cleaning and decontamination of cleanroom areas according to daily, weekly, and monthly cleaning schedules
* Perform transfer sanitisation on raw materials and consumables
* Quality Control & Compliance: Conduct visual inspection of finished products in line with product quality standards
* Carry out environmental monitoring and report deviations in accordance with SOPs
* Perform quality control checks on materials and products, ensuring they meet specifications and are released appropriately, 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
* Conduct in-process or post-manufacturing procedures (for example, labelling, packing, storage, visual inspection, discharge)
* Apply first line maintenance practices
* Store tools and equipment
* Conduct calculations (for example, 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
* 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 concentration)
* 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
* 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
* Clean equipment and process areas in-between production to avoid cross-contamination
* Conduct volume checks
* Calibrate analytical equipment
* 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
* Conduct in-process or post-manufacturing procedures (for example, labelling, packing, storage, visual inspection, discharge)
* Apply first line maintenance practices
* Store tools and equipment
* Conduct calculations (for example, 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
Qualifications
* GCSE in English (grade C/4 or above) and Maths (grade C/4 or above)
* Share if you have other relevant qualifications and industry experience. The apprenticeship can be adjusted to reflect what you already know.
* Communication skills
* Attention to detail
* Organisation skills
* Problem solving skills
* Analytical skills
* Logical
* Team working
* Initiative
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