My client is seeking an experienced CQV (Commissioning, Qualification, and Validation) Engineer to support a high-impact capital project in a drug substance manufacturing environment. This is a contract position for a skilled professional with a proven background in CQV delivery across equipment and utility systems within GMP-regulated facilities.The successful candidate will contribute to the execution of a fast-paced CQV program, working independently or as part of a cross-functional team to ensure timely and compliant system readiness for GMP operations.Key Responsibilities:Deliver full-cycle CQV documentation including URS, DQ, FAT/SAT, IQ, OQ, and support PQ activities where requiredCommission equipment and systems, verifying installation, utility integration, control functionality, and safety featuresLead CQV activities across systems such as:Bioreactors and single-use technologiesChromatography columnsCIP and SIP systemsWFI, clean steam, and process gasesProcess tanks, skids, and associated pipingConduct impact assessments and risk assessments (e.g. ASTM E2500) and define qualification strategiesCollaborate with vendors, automation, engineering, and quality teams to coordinate execution and resolve issuesLead or support resolution of deviations, non-conformances, and change controlsMaintain GMP-compliant documentation with attention to data integrityProvide regular progress updates and support system readiness reviews and handover milestonesRequired Experience & Qualifications:Bachelor's degree in Engineering, Life Sciences, or a related fieldMinimum 5 years of CQV experience in drug substance or biologics manufacturing under GMPHands-on experience with commissioning and qualification of:Large-scale bioprocess equipmentUtility systems (e.g. WFI, HVAC, compressed gases, clean steam)Automation-integrated systems (e.g. DeltaV)Strong knowledge of CQV best practices and industry standards (ISPE Baseline Guides, GAMP 5, ASTM E2500)Prior involvement in capital projects from construction through handoverAbility to work independently on protocol generation, execution, and deviation resolutionThe Next Step for you:Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.Next Generation will never share your data outside of our organisation without your prior written consent.Please read our Data Protection Policy on our website.If you require any reasonable accommodations during the recruitment process please let us know and we will do our best to support you.
