Global MS&T Process Engineer (Fill & Finish) | Biologist (m/w/d)
BioNTech SE
Job Summary
This role involves serving as a Global MS&T Process Engineer focused on Fill & Finish operations, responsible for adapting, optimizing, and implementing critical manufacturing processes to ensure efficient, high-quality production. The successful candidate will lead technology transfer activities, including comparability assessments and process performance qualification, while acting as a vital interface between internal stakeholders (TechDev, CMC) and external manufacturing partners. A core component of the job is ensuring rigorous GMP compliance, leading investigations, handling deviations, and contributing to the harmonization of process standards across various sites. Candidates must possess a university degree in Life Sciences or Engineering, coupled with 3-5 years of experience in biotech or pharmaceutical manufacturing, and proven expertise in Fill & Finish process engineering.
Required Skills
Education
University degree in Life Sciences, Engineering, or related field.
Experience
- 3-5 years of experience in the life science industry
- Professional experience in biotech or pharmaceutical manufacturing
- Proven expertise in Fill & Finish process engineering and technology transfer
- Experience in GxP compliance consulting, risk analysis, and URS development (preferred)
Languages
Additional
- Lean and Six Sigma qualifications preferred.
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