Commissioning and Qualification Engineer

Responsibilities

• Plan, prepare, review and execute C&Q documentation, including risk assessments, commissioning plans, traceability matrices and IQ/OQ/PQ protocols.
• Support the commissioning and qualification of manufacturing equipment, clean utilities, facilities and laboratory systems.
• Review vendor documentation, equipment drawings, P&IDs, technical specifications and turnover packages to confirm systems are ready for qualification.
• Conduct system walkdowns and support activities such as pressure testing, flushing, passivation, sampling and verification of critical operating parameters.
• Identify, document and resolve deviations, punch-list items and qualification issues.
• Work closely with Engineering, Quality, Operations, vendors and other stakeholders to ensure systems are delivered in accordance with project requirements and GMP standards.
• Support CAPEX projects from design and vendor engagement through installation, commissioning, qualification and handover to operations.
• Manage change controls, deviations and qualification close-out reports, ensuring all documentation is completed accurately and on time.

Qualifications and Experience

• Degree or equivalent qualification in Engineering, Life Sciences or a related technical discipline.
• Relevant experience in a C&Q, Validation or Engineering role within the pharmaceutical, biotechnology or regulated manufacturing industry.
• Strong knowledge of GMP requirements and the full qualification lifecycle.
• Hands-on experience qualifying manufacturing equipment, utilities, facilities or laboratory systems.
• Experience with clean utility systems, including Purified Water, Water for Injection, Clean Steam and Process Gases.
• Laboratory equipment and systems qualification experience, such as incubators, stability chambers, freezers, refrigerators or analytical equipment, is desirable.
• Autoclave qualification experience, including cycle development, temperature mapping and heat distribution or penetration studies, would be an advantage.
• Experience supporting CAPEX projects within a GMP-regulated environment.
• Familiarity with risk-based qualification, change control and deviation management processes.