Process Engineer global MS&T (m/w/d)

Mainz, Germany | full time | Job ID: 9827

As Process Engineer global MS&T Fill & Finish, you will be responsible for adapting, optimizing, and implementing manufacturing processes and supporting technical projects. You will act as a key interface between internal and external stakeholders, ensuring GMP compliance, process robustness, and operational readiness.

Key Responsibilities:

• Adapt, optimize, and implement Fill & Finish manufacturing processes to ensure efficient, high-quality production.
• Lead and support technology transfer activities, including comparability assessments and process performance qualification.
• Serve as interface between internal stakeholders (e.g., TechDev, CMC) and manufacturing partners to manage workflows and timelines.
• Contribute to the implementation of process standards and harmonization across products and sites.
• Lead investigations and problem-solving activities for owned processes, including deviation handling and CAPA.
• Support the development and monitoring of KPIs and process risk management strategies.
• Review and contribute to GMP documentation, including SOPs, change controls, and qualification protocols.
• Collaborate with cross-functional teams to ensure alignment on process design, regulatory compliance, and operational execution.

Qualifications & Experience

• University degree in Life Sciences, Engineering, or related field.
• 3–5 years of experience in the life science industry, ideally in biotech or pharmaceutical manufacturing.
• Proven expertise in Fill & Finish process engineering and technology transfer.
• Strong knowledge of EU/US GMP guidelines and regulatory standards.
• Experience in GxP compliance consulting, risk analysis, and URS development is a plus.
• Strategic and analytical thinking with the ability to assess risks and make balanced decisions.
• Excellent process management skills; Lean and Six Sigma qualifications preferred.
• Strong documentation and analytical skills, including statistical process monitoring.
• High team spirit and collaboration skills; ability to work cross-functionally.
• Fluent in German and English; additional languages are a plus.

Your Benefits:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germanylocation by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 9827 (please always specify if you have any questions)

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.