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).
Your Responsibilities
* 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.
Your Profile
* 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.
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