Description
We are recruiting for a Validation specialist within biologics who will be responsible to write process and cleaning validation reports which will serve as source documents for a BLA (Biologics License Application).Please note that this is a contract postion on a 6 month rolling contract.
Requirements:
- 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 are looking for experts in biotech drug substance manufacturing process validationLanguages: English fluent (must), German (is a plus) Education (minimum): BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.
Please get in touch Luchele.mendes (at the rate of) mbaswitzerland.com or call
Michael Bailey International is acting as an Employment Business in relation to this vacancy.