Process Engineer* Fill & Finish
Become a member of the BioNTech Family!
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.
Process Engineers* Fill & Finish
Your main responsibilities are:
- Lead technical transfer activities for commercial scale-up or launches and transfers between sites or from sites to Contract Manufacturing and ensure on-time execution for manufacturing processes of his discipling (e.g. DS), incl. GMP documentation for regulatory approval
- Design and conduct process qualification and validation and drive continuous improvement of process robustness; Monitoring for BNT of product/process parameters
- Lead end-to-end change control management (e.g., working with Tech Development, Regulatory, QA)
- Investigate and problem solve upcoming process issues; Support new process design and risk assessment for new initiatives
- Provide support on technical processes to other teams, share lessons learnt
What you have to offer.
- University degree in (Life) Science or Engineering
- 3 to 5 year´s of experience in the life science industry (ideally a biotech or pharmaceutical company)
- Several years of practical experience and expertise in Fill & Finish process engineering
- Experience with technology transfer of Biotech products, methods for technology transfer comparability assessments, and process performance qualification
- Profound knowledge of EU / US GMP guidelines and regulatory standards
- Strategic and analytical thinking skills to identify risks and prepare balanced decisions
- Excellent process management skills, Lean and Six Sigma qualifications preferred
- Creativity and the ability to develop a flexible approach to changing conditions, distinct analytical and conceptual competencies
- High team spirit and excellent collaborating skills
- Good communication skills, fluency in German and English
Benefits for you.
- Company Pension Scheme
- Company Bike
- Leave Account
- Fitness Courses
- Mobile Office
- Special Vacation
Have we kindled your pioneering spirit?
If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291
(monday-friday, from 12 noon to 4 pm).
Job-ID 4242 (please indicate for inquiries)
We look forward to your application!
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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