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

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries
? PQE Group has been at the forefront of these industries since 1998
, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas
.

We are currently seeking a skilled Technical CSV/CnQ Specialists with experience in the Life Sciences industry to support validation and qualification documentation activities within a long-term project.

The candidate will be responsible for the authoring, review, and lifecycle management of validation and qualification documentation, ensuring compliance with GxP requirements and industry standards.

This position is part of a long-term project based in the 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 min. 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
• Fluent in German and English

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal.

Alternatively, if the outcome is negative, we will contact you to halt the recruitment process.

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation
. PQE Group gives you the opportunity to work on international projects
, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career
, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.