CQV Engineer

CQV Engineer – 6862

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is recruiting for a talented CQV Engineer to be based in Stein, Switzerland.

As a CQV Engineer you will play a critical role in ensuring compliance and excellence in pharmaceutical manufacturing operations. You'll be at the heart of new plant implementations, overseeing the qualification lifecycle from commissioning through to operational support, while collaborating with cross-functional teams to maintain the highest regulatory standards. This is a 6-month contract with a chance of extension.

• Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems and ongoing SLC support post-implementation.
• Supervise and resolve deviations, manage changes (GEP and GMP), and implement CAPAs effectively.
• Coordinate efforts between internal teams and external service providers and suppliers to ensure seamless project execution.
• Present qualification documents during audits and inspections, showcasing the outstanding standards maintained.

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required
• Graduate from a technical school (HF) / university of applied sciences (FH) or hold a university degree
• Proven experience in a regulated GMP environment, specifically in commissioning, qualification, and validation of systems like refrigerators, freezers, clean media, and process engineering equipment
• Strong proficiency in MS Office; familiarity with OMOS, DMS, Kneat, Track Wise, and SAP is advantageous
• Proficient in both written and spoken German and/or English
• Demonstrate independent, flexible work habits, with excellent communication skills and a structured, focused approach to tasks.
• Open to new ideas, agile in thinking, and proactive in problem-solving.