Bioprocess Engineer (Upstream Processing), GMP Biopharmaceuticals | Bioprozessingenieur im Bereich GMP-Biopharmazeutika (all genders) - Schwerpunkt Upstream Processing
Fraunhofer-Gesellschaft e.V. Zentrale München
Job Summary
The Fraunhofer Institute IZI is seeking a Bioprocess Engineer specializing in Upstream Processing (USP) to join the GMP Biopharmaceuticals group in Leipzig. This role is crucial for advancing medical progress by developing, manufacturing, and ensuring the quality control of modern biotechnological medicines for preclinical and clinical trials, strictly adhering to Good Manufacturing Practice (GMP) standards. Day-to-day responsibilities involve leading complex GMP projects focused on USP, including comprehensive project management, material planning, and coordination with external partners. The engineer will utilize technical expertise to design and implement new USP processes, contribute to manufacturing process optimization, and provide technical guidance to staff. A core function is creating and maintaining essential GMP technical documentation to ensure the traceability and quality of all process steps. Candidates must hold a relevant university degree and possess practical experience in cleanroom environments (up to Class A) and with mammalian cell cultures and bioreactors up to 200 liters. This position offers the opportunity to actively shape the future of medicine within a leading European applied research organization.
Required Skills
Education
University degree in Natural Sciences or Engineering (e.g., Biotechnology, Pharmaceutical Engineering, Bioprocess Engineering/Biosystems Engineering) or a comparable field
Experience
- Practical experience working in a cleanroom (up to cleanroom class A) and under GMP conditions
- Experience with regulatory requirements in the GMP environment, especially the EU-GMP Guide Annex I
- Professional experience handling mammalian cell cultures
- Professional experience operating wave reactors and stirred bioreactors up to 200 liters
Languages
Additional
- Initially limited contract duration of two years (further employment is sought); Location: Leipzig; Requirement for meticulous and conscientious work style for GMP compliance; Willingness to work weekends in rare cases.
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