CK QLS

Computer System Validation Engineer

CK QLS are recruiting for a Computer System Validation (CSV) Engineer to join a leading global pharmaceutical company’s Analytical R&D (AR&D) site in Switzerland. This is an excellent opportunity to contribute to metrology and validation activities within a GMP-regulated laboratory environment.

Role Overview

As part of the Metrology & Validation team, you will support the qualification and validation of analytical instrumentation and computerised systems, ensuring compliance and inspection readiness across the site. You will collaborate with global teams across Europe and the US, contributing to both local and international projects.

Key Responsibilities

• Coordinate and execute equipment qualification and computer system validation activities.
• Support full system lifecycle activities including procurement, validation, maintenance, upgrades, and decommissioning.
• Perform SDLC validation activities in collaboration with IT and site validation teams.
• Ensure calibration and maintenance of analytical instruments in line with defined schedules.
• Support metrology and validation-related site projects and initiatives.
• Troubleshoot issues with laboratory instruments and provide technical support.
• Author and review SOPs, change controls, deviation reports, and periodic reviews.
• Support deviation investigations and CAPA activities.
• Work cross-functionally with laboratory teams, engineers, and quality functions.

Candidate Requirements

• Degree or technical qualification in Biotechnology, Chemistry, Biochemistry, Engineering, IT, or related field.
• Proven experience in Computer System Validation (CSV) within a GMP environment.
• Experience with analytical laboratory equipment (e.g. HPLC, qPCR, plate readers).
• Strong understanding of GMP requirements and quality processes.
• Experience with equipment qualification, commissioning, or validation lifecycle activities.
• Strong documentation skills and attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.
• Fluent in English (B1+) and German (B2+).

Desirable Experience

• Experience with calibration and maintenance of laboratory equipment.
• Knowledge of change control, deviation, and CAPA processes.
• Experience in auditing and compliance within pharmaceutical environments.
• Familiarity with project management tools and methodologies.

Additional Information

• Site-based role (5 days per week) with limited home office flexibility.
• Opportunity to work within a global pharmaceutical environment.
• Exposure to cross-functional and international collaboration.

For more information or to apply, please contact CK QLS. It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 181487 in all correspondence.