Specialist, Manufacturing Processes (Visual Inspection and Packaging) | Chemiker (m/w/d)
BioNTech SE
Job Summary
This role supports the production of individualized neoantigen specific cancer therapeutics in Mainz, focusing on visual inspection and packaging processes. The Specialist acts as a key support for Subject Matter Experts (SMEs), utilizing in-depth process knowledge to ensure smooth daily operations. Key responsibilities include performing root cause analysis and risk assessments for process deviations, defining and implementing corrective and preventive actions (CAPA management), and coordinating change control procedures. Furthermore, the role involves creating crucial area-specific GMP documentation, such as SOPs and working procedures, and supporting device qualification efforts. Candidates must possess a university degree in a scientific or technical field (e.g., Chemistry, Engineering) and at least two years of relevant experience in a GMP-regulated biotech or pharmaceutical environment, demonstrating strong knowledge of EU GxP regulations and meticulous attention to detail.
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.
- Professional experience in GMP documentation, visual inspection, and packaging.
- Experience in device qualification, ideally in a biotech or pharmaceutical company.
- Experience in deviation, CAPA, and Change management.
Languages
Additional
- Location in Mainz, Germany
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