Computer System Validation Engineer
CK QLS
are currently seeking a Computer System Validation (CSV) Engineer to join a Metrology & Validation team within Analytical Research & Development at a GMP-regulated pharmaceutical site in Switzerland.
This site-based role offers the opportunity to work closely with analytical laboratories, quality, IT, and global validation partners, ensuring analytical instruments and computerized systems remain in a state of permanent inspection readiness.
Key Responsibilities
- Coordinate and execute qualification of analytical instruments and equipment
- Perform Computer System Validation activities across the system lifecycle (SDLC)
- Support metrology activities including calibration planning and execution
- Manage system and equipment lifecycle activities such as upgrades, maintenance, and decommissioning
- Author and maintain SOPs, change controls, periodic reviews, and validation documentation
- Support deviation investigations and CAPA activities
- Provide technical troubleshooting support for laboratory equipment
- Technical education or university degree in biotechnology, analytical chemistry, biochemistry, IT, or a related field
- Experience in Computer System Validation, Commissioning & Qualification, or GMP laboratory environments
- Strong documentation skills and high attention to detail
- Ability to work independently and within cross-functional teams
- Strong communication skills in German (B2) and English (B1)
- Experience with analytical instrumentation, controlled temperature units, audits, or change management is an advantage
- Site-based role, five days per week
- Limited home office possible on a need basis
- Typical working hours start between 07:00 and 08:45
- Candidates with longer notice periods will be considered
- Responsibilities can be adjusted based on experience and career ambitions
- If you are motivated by quality, compliance, and working close to the laboratory in a regulated environment, this role offers strong development potential.