Chemical or Biotechnological Support (m/f)

- Maintaining operational readiness of pilot manufacturing processes
- Maintaining and extending process knowledge base
- Trouble-shooting and streamlining of process by designing scale-up and scale-down experiments
- Participate in project groups with manufacturing, QC & QA
- Translate operational requirements into project plans, taking into account regulatory requirements
- Conduct transfer of process modifications according to the project plan
- Designing and directing pilot processes
- Write operating procedures and batch protocols for pilot processes according to cGMP
- Verify comparability between pilot and commercial processes
- Cross-training in clean room and process procedures
- Preparation of pilot process batch records
- Analyzing and documenting pilot process performances
- Verifying comparability between pilot and commercial processes

- Degree in Chemical or Biotechnological Engineering (Dipl-Ing, M. Eng. or equivalent)
- Work experience in fermentation or cell culture in a cGMP environment
- Work experience in API and/or DP production in a cGMP environment
- Experience in biopharmaceutical equipment qualification and process validation
- Fluent in German and English with excellent communication and written skills
- Experience in process scale-up and scale-down from lab or pilot to production scale, experience with process improvement tools, e.g. FMEA and six sigma as well as experience with GEP are nice to have

Weitere Qualifikationen: QM manager, Project manager