About the Role

We are seeking a mid-level Commissioning, Qualification & Validation (CQV) Engineer to join our project team for a 6-month contract. The successful candidate will be focused on the execution phase of a large-scale project, with heavy involvement in IQ, OQ, and PQ activities. This is a hands-on role requiring close collaboration with cross-functional teams, vendors, and stakeholders to ensure equipment and systems are installed, qualified, and validated in compliance with GMP and project requirements.

Key Responsibilities

• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for process equipment, utilities, and systems.

• Review and execute test protocols, reports, and traceability matrices.

• Support troubleshooting during qualification and validation execution.

• Ensure all documentation is completed to GMP standards and project timelines.

• Liaise with vendors, contractors, and internal teams during execution.

• Provide technical input to deviations, CAPAs, and change controls related to qualification.

• Participate in daily project meetings and provide progress updates.

• Ensure compliance with regulatory requirements (FDA, EMA, and relevant EU GMP guidelines).

Qualifications & Experience

• Degree in Engineering, Life Sciences, or a related discipline.

• 3–6 years’ experience in CQV within the pharmaceutical or biotech industry.

• Strong knowledge of IQ/OQ/PQ execution and GMP compliance.

• Proven experience with commissioning and qualification of equipment/utilities (e.g., process vessels, autoclaves, clean utilities, HVAC).

• Experience in deviation management and technical problem-solving.

• Excellent communication and documentation skills.

• Fluency in French is essential; working proficiency in English is a strong advantage.