Process Engineer, Upstream Processing (USP) | Prozess Ingenieur im Upstream Processing (USP) (m/w/d), Herbert-Bayer-Straße 8
ProBioGen AG
Job Summary
This role involves the planning, organization, and execution of Upstream Processing (USP) production projects, spanning both lab-scale (10-50 L) and large-scale (up to 1000 L) operations under R&D and strict GMP conditions. The Process Engineer will independently lead USP production projects, collaborating closely with Development, DSP (Downstream Processing), and Project Management teams. Key daily activities include organizing and conducting Non-GMP/Tox and GMP production processes, managing documentation, sample coordination, and material logistics. A critical component is the creation, maintenance, and revision of GMP documentation, such as SOPs, manufacturing documents, and risk analyses, with reporting and presentations often required in English. The ideal candidate holds a Master's degree in Biotechnology or Bioprocess Engineering, possesses experience with bioreactors and cell culture processes (e.g., CHO, Fed-batch), and demonstrates strong organizational and communication skills, coupled with a solution-oriented mindset. The position is permanent and requires adherence to cleanroom protocols, including scheduled weekend shifts.
Required Skills
Education
Completed university degree (Diploma or Master) in Biotechnology, Bioprocess Engineering, or comparable field
Experience
- Experience with bioreactors, cell culture processes, and aseptic working
- Professional experience in the biopharmaceutical production environment (desirable)
- Basic knowledge of the GMP environment and ISO standards (advantageous)
Languages
Additional
- Must perform cleanroom work; Required to perform scheduled weekend shifts; Adherence to all GMP, training, and safety requirements
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