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

BioNTech SE; Mainz; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A biotechnology company in Mainz, Germany, seeks a Process Engineer for Fill & Finish to optimize and implement manufacturing processes, ensuring GMP compliance and operational readiness. The ideal candidate should have a degree in Life Sciences or Engineering and 3-5 years of relevant experience in biotech or pharmaceuticals. Responsibilities include leading technology transfers and collaborating across teams. Flexible hours and opportunities for development are part of the offer.

Leistungen

Flexible hours

Digital Learning

Company bike

Employer-funded pension

Childcare

Qualifikationen

• 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.

Aufgaben

• Adapt, optimize, and implement manufacturing processes for efficient production.
• Lead and support technology transfer activities.
• Collaborate with cross-functional teams on process design and execution.

Kenntnisse

Fill & Finish process engineering

GMP compliance

Process management

Lean and Six Sigma

Fluent in German

Fluent in English

Ausbildung

University degree in Life Sciences or Engineering

Jobbeschreibung

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

• 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

Apply to our Mainz, Germany location 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.

BioNTech does not tolerate discrimination, favoritism or harassment based on gender, political views, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other physical or personal characteristics. BioNTech is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer. The main thing is that you suit us, and we suit you!

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