Technical CSV​/CnQ Specialists; Pharma​/Life Sciences

Technical CSV/CnQ Specialist

Join a world leader in the Pharmaceutical and Medical Device industries. PQE Group has been a global player since 1998, operating 40 subsidiaries and 2000+ employees across Europe, Asia and the Americas.

This role supports validation and qualification documentation activities within a long‑term project based in Canton Bern, Switzerland and requires 100% on‑site presence.

• Preparation and maintenance of validation and qualification documentation in accordance with GxP standards.
• Protocol generation (e.g., IQ, OQ, PQ) ensuring accuracy and compliance.
• Report generation, including execution reports and final documentation packages.
• Creation of summary reports for validation and qualification activities.
• Management of documentation within Kneat systems, ensuring proper structure and traceability.
• Support the documentation lifecycle, including review, approval, revision, and archival processes.
• Collaborate with cross‑functional teams (engineering, QA, validation) to ensure document completeness and alignment.

• Proven experience of at least 5 years as a Technical Writer in the Life Sciences or pharmaceutical industry.
• Strong expertise in GxP documentation practices.
• Hands‑on experience with validation and qualification documentation.
• Familiarity with Kneat or similar electronic validation lifecycle management systems.
• Excellent attention to detail and strong organizational skills.
• Ability to manage multiple documents and deadlines in a structured manner.
• Fluency in German and English.

Canton Bern, Switzerland (100% on‑site).