Description
We are looking for a
Chemical or Biotechnological Support (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM
Ort: in North Rhine-Westphalia
Branche: Sonstige Forschung und Entwicklung im Bereich Natur-, Ingenieur-, Agrarwissenschaften und Medizin
Ihre Aufgaben:
- Maintaining operational readiness of pilot manufacturing process
- 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 process
- Write operating procedures and batch protocol for pilot process according to cGMP
- Verify comparability between pilot and commercial process
- Cross-training in clean room and process procedures
- Preparation of pilot process batch record
- Analyzing and documenting pilot process performance
- Verifying comparability between pilot and commercial process
Ihre Qualifikation
- Must Have:
- Degree in Chemical or Biotechnological Engineering (Dipl-Ing, M. Eng. or equivalent)
- Work experience (NLT 5 yrs) in fermentation or cell culture in a cGMP environment
- Work experience (NLT 5 yrs) 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
- Bonus:
- 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
- Experience with GEP
Skills:
- QM manager