Process Validation Expert - Biologics

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 position 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 validation

Languages: English fluent (must), German (is a plus)
Education (minimum): BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.

PLEASE GET IN TOUCH

Michael Bailey International is acting as an Employment Business in relation to this vacancy.