Process Engineer for Cell and Gene Therapy | Prozess Ingenieur für Zell-u. Gentherapie (m/w/d)
ProBioGen AG
Job Summary
This role is based in Berlin within a leading BioTech company, focusing on the development and operation of a new production facility for Cell and Gene Therapies. The Process Engineer will be instrumental in the planning, establishment, and commissioning phases of this state-of-the-art facility. Key responsibilities include planning and procuring necessary equipment for cell therapeutic work, as well as Upstream Processing (USP) and Downstream Processing (DSP) for gene therapeutic products. A major component of the job involves overseeing equipment qualification processes, including FAT, SAT, IQ/OQ, and executing Performance Qualification (PQ) protocols. Candidates must hold a Master's degree or equivalent in Bioprocess Engineering or Biotechnology, possess experience in equipment qualification and facility planning, and demonstrate foundational knowledge of GMP standards. This position offers the opportunity to drive innovation in medical therapies within a supportive and collaborative environment.
Required Skills
Education
Completed degree (Dipl.-Ing. or Master) in Bioprocess Engineering, Biotechnology, or a comparable field.
Experience
- Experience in equipment qualification
- Experience in facility planning
- Ideally, experience in cell and gene therapy processes
Languages
Additional
- Willingness to travel for business trips (e.g., FAT of equipment, process transfer).
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