Commissioning Engineer (Clean Utilities))

Overview
A leading pharmaceutical manufacturing site is seeking an experienced CQV Engineer to support commissioning and qualification activities for Clean Utility systems as part of a major sterile drug product facility expansion. This role is 100% onsite and reports into the Area CQV Lead. The successful candidate will contribute to the full CQV lifecycle - from documentation through to execution and final handover.

Key Responsibilities

• Generate and execute CQV documentation for Clean Utilities (PW, WFI, Clean Steam, Process Gases)

• Perform on-site commissioning, OQ execution, and deviation management

• Participate in FATs and leverage results into site qualification

• Ensure compliance with GMP, EU/FDA regulations, and internal procedures

• Manage qualification risks and mitigation actions

• Maintain detailed records using electronic validation systems (e.g. Kneat, IDA)

• Collaborate with cross-functional teams and support project timelines

Required Experience

• 5-10 years' CQV experience in pharmaceutical or biotech environments

• Proven expertise in Clean Utilities (WFI, Purified Water, Clean Steam, Gases)

• Strong documentation and protocol execution skills (especially OQ)

• Familiarity with electronic validation platforms (e.g. Kneat, ValGenesis, IDA)

• Background in sterile drug product facilities highly desirable

• Excellent stakeholder engagement and project delivery mindset

Education

• Degree-qualified in Engineering, Science, or related technical discipline