Commissioning Engineer (Clean Utilities))
- Dublin
- Contract
- Full-time
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 ResponsibilitiesGenerate and execute CQV documentation for Clean Utilities (PW, WFI, Clean Steam, Process Gases)Perform on-site commissioning, OQ execution, and deviation managementParticipate in FATs and leverage results into site qualificationEnsure compliance with GMP, EU/FDA regulations, and internal proceduresManage qualification risks and mitigation actionsMaintain detailed records using electronic validation systems (e.g. Kneat, IDA)Collaborate with cross-functional teams and support project timelinesRequired Experience5-10 years' CQV experience in pharmaceutical or biotech environmentsProven 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 desirableExcellent stakeholder engagement and project delivery mindsetEducationDegree-qualified in Engineering, Science, or related technical discipline