Commissioning & Qualification Engineer

Commissioning & Qualification Engineer (100%)

Location: Switzerland

Work model: On-site (limited hybrid flexibility)

Contract: Permanent, full-time

About the Role

A leading pharmaceutical R&D organization in Switzerland is seeking a Commissioning & Qualification Engineer to join its Metrology & Validation function within an analytical laboratory environment. This role plays a key part in ensuring analytical equipment and computer systems remain in a continuous state of GMP compliance and inspection readiness.

The position offers strong development potential and close collaboration with cross-functional stakeholders at both local and global level.

Key Responsibilities

• Plan, coordinate, and execute commissioning, qualification, and validation activities for analytical equipment
• Perform Computer System Validation (CSV), including SDLC activities, in collaboration with IT and Quality teams
• Manage equipment lifecycle activities such as purchasing, maintenance, calibration, and decommissioning
• Support analytical metrology programs and ensure calibration schedules are maintained
• Author and maintain GMP documentation including SOPs, change controls, periodic reviews, and validation reports
• Support deviation investigations, CAPA activities, and change management processes
• Collaborate with laboratory teams to support site-wide projects and continuous improvement initiatives

Candidate Profile

Education:

• Technical education or apprenticeship in pharmaceutical, biotech, IT, or related technical fields, or
• University degree in analytical chemistry, biotechnology, biochemistry, or a related discipline

Experience & Skills:

• Hands-on experience in Commissioning & Qualification and/or Computer System Validation (CSV)
• Experience working in GMP-regulated laboratory environments
• Strong documentation skills with high attention to detail
• Ability to work independently and within cross-functional teams
• Proactive, solution-oriented mindset with strong organizational skills
• Fluency in English (minimum B1) and German (minimum B2)

Preferred / Advantageous:

• Experience with controlled-temperature units, incubators, or stability chambers
• Knowledge of change management, deviation handling, and CAPA processes
• Experience in auditing and regulatory inspections
• Technical affinity for laboratory equipment and IT-related systems

Working Conditions

• Site-based role, 5 days per week
• Home office possible on an ad-hoc basis, subject to operational needs
• Candidates with longer notice periods will be considered