Commissioning & Qualification Engineer

About the role

The Commissioning & Qualification (C&Q) Engineer will lead the execution of commissioning, qualification and start‑up activities for large‑scale pharmaceutical or biotech projects. Reporting to the project team, you will ensure that all systems are safely installed, verified and compliant with GMP/GEP standards before hand‑over to operations.

Key responsibilities

• Prepare and maintain lifecycle documentation, including Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Develop, execute and review Factory Acceptance Testing (FAT), Commissioning and Site Acceptance Testing (SAT) procedures.
• Conduct design reviews, design qualification activities and system walk‑downs to transfer ownership from construction to operations.
• Perform installation verification, functional testing and support system start‑up activities.
• Coordinate with contractors, vendors and internal stakeholders such as construction, engineering, automation, quality and end‑users.
• Participate in change management, track daily tasks, and compile summary reports and final documentation packages.

Required profile

• Degree in Science or Engineering, or equivalent technical diploma with relevant industrial experience.
• Minimum five years of hands‑on C&Q experience on large‑scale pharmaceutical or biotech projects.
• Strong understanding of GMP and GEP regulatory and industry standards.
• Self‑motivated, able to work independently and as part of a multidisciplinary team.
• Excellent oral and written communication skills.

Required skills

• Experience with Black and Clean Utilities.
• Knowledge of purification equipment, reactors, filtration equipment and CIP systems.
• Familiarity with upstream and downstream process equipment.
• Proficiency in preparing and executing IQ, OQ, FAT, SAT and design qualification protocols.