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