Commissioning & Qualification Engineer (Pharma)

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. You will work closely with construction, engineering, automation, quality and end‑user teams to ensure systems are safely transferred to operations.

Key responsibilities

• Prepare lifecycle documentation for Installation Qualification (IQ), Operational Qualification (OQ) and related activities.
• Develop and execute Factory Acceptance Testing (FAT), Commissioning and Site Acceptance Testing (SAT) protocols.
• Conduct design reviews (DR) and design qualification (DQ) activities.
• Perform system field walkdowns, installation verification and functional testing.
• Support system start‑up, change management and safe operation during qualification phases.
• Coordinate with contractors, vendors and project stakeholders across all phases.
• Produce summary reports and final documentation packages.

Required profile

• Degree in Science or Engineering, or equivalent diploma with relevant industrial experience.
• Minimum 5 years of hands‑on C&Q experience on large‑scale pharma or biotech projects.
• Strong understanding of GMP and GEP regulatory standards.
• Self‑motivated, able to work independently and within multidisciplinary teams.

Required skills

• Experience with black and clean utilities.
• Knowledge of purification equipment, reactors and filtration equipment.
• Familiarity with Clean‑In‑Place (CIP) systems.
• Upstream and/or downstream process equipment expertise.