Global MS&T Process Engineer | Life Scientist (m/w/d)
BioNTech SE
Job Summary
This critical role involves adapting, optimizing, and implementing Fill & Finish manufacturing processes to ensure highly efficient and compliant production within the life science industry. The Process Engineer acts as a vital interface, managing workflows and timelines between internal stakeholders (such as TechDev and CMC) and external manufacturing partners. Key responsibilities include leading technology transfer activities, conducting comparability assessments, and ensuring rigorous adherence to EU/US GMP guidelines and regulatory standards. The position requires proactive involvement in process harmonization across sites, leading complex investigations (including deviation handling and CAPA), and contributing to process risk management strategies. Candidates must possess a university degree in Life Sciences or Engineering, coupled with 3-5 years of direct experience in biotech or pharmaceutical manufacturing, specifically demonstrating expertise in Fill & Finish process engineering. Fluency in both German and English is mandatory for effective cross-functional and international collaboration.
Required Skills
Education
University degree in Life Sciences, Engineering, or related field
Experience
- 3-5 years in the life science industry, ideally in biotech or pharmaceutical manufacturing
- Proven expertise in Fill & Finish process engineering and technology transfer
- Professional experience leading investigations and problem-solving activities for manufacturing processes
Languages
Additional
- Must be able to work full-time in Mainz, Germany
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