CQV Consultant

We are looking for a CQV Engineer to join our teams in Switzerland and support commissioning, qualification, and validation activities for pharmaceutical facilities, equipment, and utilities. The position is a permanent contract and a consultant role within our Life Sciences experts (not a contractor).

• Plan, coordinate, and execute commissioning and qualification activities for GMP equipment, systems, and facilities in line with project requirements.
• Prepare, review, and approve CQV documentation including URS, risk assessments, commissioning protocols, qualification protocols (IQ, OQ, PQ), and summary reports.
• Ensure that CQV deliverables comply with current GMP, regulatory standards, and company procedures.
• Collaborate closely with cross-functional teams including Engineering, Operations, QA, and external service providers to ensure successful project delivery.
• Support execution of qualification testing and oversee external vendors during commissioning and validation phases.
• Manage deviations, CAPAs, and change controls to ensure timely resolution and compliance.
• Participate in audits and inspections, providing CQV expertise and ensuring readiness of documentation and systems.
• Contribute to continuous improvement initiatives, process optimization, and knowledge sharing across CQV teams.

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical field.
• Experience in commissioning, qualification, and validation activities within the pharmaceutical or biotechnology industry.
• Solid knowledge of GMP regulations and industry guidelines (FDA, EMA, ISPE, GAMP).
• Strong technical writing and documentation skills for validation deliverables.
• Hands‑on experience with equipment and/or utilities qualification is an advantage.
• Excellent communication and teamwork skills, with the ability to coordinate across departments and external providers.
• Analytical mindset with problem-solving and risk assessment capabilities.
• Flexible, proactive, and adaptable to dynamic project environments.
• Fluency in English;
  German or French is an asset depending on project location.