Bioprocess Engineer for GMP Biopharmaceuticals - Downstream Processing Focus | Bioprozessingenieur für GMP-Biopharmazeutika (all genders) - Schwerpunkt Downstream Processing
Fraunhofer-Gesellschaft e.V. Zentrale München
Job Summary
The Fraunhofer Institute for Cell Therapy and Immunology (IZI) is seeking a Bioprocess Engineer specializing in Downstream Processing (DSP) to join their GMP Biopharmaceuticals group in Leipzig. This role is crucial for developing modern biotechnologically produced medicines and ensuring their manufacturing and quality control adhere strictly to Good Manufacturing Practice (GMP) standards. Day-to-day, you will manage complex DSP projects, covering everything from internal coordination and project management to materials planning and communication with external partners. A core responsibility involves designing and implementing new DSP processes, providing technical guidance to staff, and creating comprehensive technical documentation compliant with GMP regulations (especially EU-GMP Annex I). The ideal candidate possesses a university degree in a relevant scientific or engineering field (e.g., Biotechnology, Bioprocess Engineering), practical experience working in cleanrooms (up to Class A), and deep knowledge of chromatographic purification and filtration techniques. This position offers the chance to actively shape the future of medicine within a leading European application-oriented research organization, supported by excellent facilities and opportunities for professional growth.
Required Skills
Education
University degree in Natural Sciences or Engineering (e.g., Biotechnology, Pharmaceutical Engineering, Bioprocess/Biosystems Engineering) or a comparable field
Experience
- Practical experience working in cleanrooms (up to and including Cleanroom Class A)
- Practical experience working under GMP conditions
- Experience in process development of chromatography, filtration, tangential flow filtration, and virus clearance
- Professional proficiency in handling equipment for chromatographic purification and filtration of biomolecules
Languages
Additional
- The position is initially limited to two years, with the aim of subsequent continued employment.
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