CQV/CSV Engineer (f/m/d)
CQV/CSV Engineer (f/m/d)
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1 Vacancy
Job Description
Location: Switzerland (various project locations)
Company: Fortil Switzerland
Employment Type: Full-time
About Fortil
At Fortil we believe in empowering engineers and consultants to lead impactful projects in life sciences energy and industrial sectors. With a presence across Europe we are committed to innovation excellence and developing tailored solutions that advance our clients success.
Your Role
As a CQV/CSV Engineer you will play a critical role in supporting commissioning qualification and validation activities for pharmaceutical manufacturing systems and equipment. You will ensure compliance with regulatory standards and drive the success of projects for our clients in Switzerland.
Your Responsibilities
- Lead and execute Commissioning Qualification and Validation (CQV) activities for GMP systems and processes
- Support and perform Computer System Validation (CSV) in compliance with GAMP and 21 CFR Part 11 requirements
- Draft review and execute validation protocols (IQ/OQ/PQ) risk assessments and related documentation
- Coordinate with cross-functional teams including QA Engineering and Manufacturing
- Ensure project milestones are delivered on time and within regulatory expectations
- Participate in client meetings audits and inspections when necessary
Your Profile
- Minimum 5 years of experience in CQV/CSV roles
- Strong background in the pharmaceutical industry (GMP environment)
- Proven experience with equipment utilities and computerized systems validation
- Bilingual: fluent in English and French; German is a strong plus
- Excellent communication and organizational skills
- EU work permit or Swiss work authorization required
Why Join Fortil
- Be part of a dynamic international consultancy with ambitious growth
- Work on cutting-edge projects in the pharmaceutical sector
- Continuous learning and professional development opportunities
Employment Type
Full Time
