Specialist Manufacturing Processes - Visual Inspection and Packaging | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This Specialist Manufacturing Processes role supports the daily operations of an individualized neoantigen specific therapy facility, focusing on visual inspection, labeling, and packaging of personalized cancer therapeutics. The successful candidate will act as support for subject matter experts (SMEs), utilizing in-depth process knowledge to ensure smooth production. Key responsibilities include executing device qualification according to GMP requirements, handling process deviations, performing root cause analysis, and defining corrective and preventive actions (CAPA management). The specialist will also coordinate change control procedures and create essential area-specific documentation (SOPs, working procedures). This position offers an independent work style within a highly critical, individualized biopharma manufacturing environment, making it attractive for detail-oriented professionals seeking significant impact in cancer therapy production.
Required Skills
Education
University degree (Bachelor or Master) in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area
Experience
- 2 years of experience in manufacturing/production or relevant experience in GMP documentation, visual inspection, packaging, and device qualification
- Experience in deviation, CAPA, and Change management
- Good knowledge of EU GxP regulations
- Professional experience, ideally in a biotech or pharmaceutical company
Languages
Additional
- Not specified
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