SUMMARY:
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POSITION INFO:
Afrigen is seeking to recruit Two (2) Filling Technicians to ensure the efficient and compliant production of mRNA vaccines. This position requires in-depth knowledge of manufacturing processes, equipment, and cGMP regulatory guidelines. You will collaborate closely with cross-functional teams to drive process optimization, quality assurance, and continuous improvement initiative.
Key Responsibilities:
- Execute batch and non-batch related fill and finish activities.
- Executing the line build and unbuild procedures on the filling machine.
- Participate and lead in aseptic process simulations.
- Perform product sterile filtration and filter integrity testing.
- Perform cleaning, pre and post glove integrity testing of the filling machine.
- Perform daily checks on Production processes/area to ensure compliance is continuously met.
- Perform transfer of materials for filling activities and other production related processes.
- Assist with batch manufacturing preparations such as equipment cleaning and sterilisation.
- Participate in various quality system elements, including systems such as deviation management, root cause analysis, CAPA, change control and quality risk management.
- Provide the required technical support to enable the production process/facility to function.
- Maintaining gowning competency requirements.
- Ensure adherence to cleanroom behaviour and compliance to cGMP requirements.
Qualifications and Experience:
- N Dip/ BTech/ Diploma in Biotechnology/ Life science/ Engineering post matric qualification. Strong technical aptitude and ability to learn and operate automated systems.
- At least 2 years in production operations and Sterile experience or pharmaceutical background.
- Good critical thinking skills and attention to detail.
- Experience with cGMP, knowledge of quality and regulatory compliance relevant to Biotech/Pharma industry.
- Excellent organisation and time management skills.
Training Requirements:
Selected candidates will be trained on aseptic techniques and gowning qualified.
