For our Swiss customer located in Basel we are currently looking for (m/f) a Process Validation Expert - Biotech Drug Substance
- Type of placement: 5 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
Duration: until end of year, but extension possible if candidate is a good fit.
The validation expert for biotech products is responsible to write process and cleaning validation reports which will serve as source documents for a BLA (Biologics License Application).
- Author process validation and cleaning validation reports for biotech drug substance processes (upstream and downstream).
- Analyze and evaluate process data from executed validation studies.
- Thorough understanding of biotech (mammalian cell based) manufacturing processes and related process equipment (USP and DSP).
- Experience in process validation.
- Expertise in reviewing and writing technical reports in English
- Experience in biotech process validation or biotech cleaning validation (plan and report writing)
- Experience in regulatory affairs particular in writing module S25 is a plus
IMPORTANT: we look for experts in biotech drug substance manufacturing process validation (NOT equipment qualification, not analytical method validation, not computer validation)
Languages: English fluent (must), German (is a plus)
Education (minimum): BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.