Process Validation Specialist

Stellenbeschreibung

# Process Validation Specialist # (m/f/d) Freelance/temporary employment for a project Lengnau, Berne Start date: asap Reference number: 887840/1 ### Responsibilities ### * Support execution of process validation activities for biotech manufacturing processes * Prepare, update, and finalize process validation protocols and reports, with a strong focus on completing outstanding validation documentation * Coordinate sampling activities and support shop floor execution in collaboration with Manufacturing and Quality Control * Assist with deviation investigations, change controls, and risk assessments related to validation activities * Ensure validation documentation complies with cGMP and internal quality requirements * Contribute to Continued Process Verification (CPV) documentation and other validation-related deliverables as needed * Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, and MSAT ### Profile ### * Bachelor's or Master's degree in Life Sciences, Biotechnology, Chemistry, Engineering, or related discipline * Strong experience in process validation within a GMP pharmaceutical or biotech manufacturing environment * Strong technical writing skills, with demonstrated experience authoring validation protocols and reports * Knowledge of upstream and/or downstream bioprocessing is preferred * Working knowledge of cGMP and validation lifecycle principles * Ability to work independently while supporting a broader validation team ### Benefits ### * Renowned pharmaceutical company * Attractive salary package