CQV / Validation Engineer (Equipment Qualification) OutsideIR35

Your new company A leading pharmaceutical manufacturing organisation is seeking an experienced CQV / Validation Engineer to support a programme of new asset introduction and qualification activities within a GMP regulated environment. Working alongside Engineering, Quality, Manufacturing and Project teams, you'll play a key role in ensuring critical equipment, facilities and utilities are introduced and maintained in a validated state. Your new role As the Validation Engineer, you will be responsible for delivering qualification and validation activities across laboratory and manufacturing systems. Key responsibilities will include: • Authoring, reviewing and executing validation documentation including Validation Plans, Risk Assessments, IQ, OQ and PQ protocols and Validation Summary Reports. • Supporting new equipment introduction projects from planning through to GMP release. • Executing qualification activities for manufacturing and laboratory equipment. • Performing thermal mapping activities on controlled temperature units (CTUs), including fridges, freezers, incubators and other GMP systems. • Supporting qualification activities for equipment such as lyophilisers, sterilisers and associated utilities. • Conducting pre-calibration and post-calibration activities. • Managing deviations, investigations, CAPAs and change controls. • Analysing qualification data and producing technical reports. • Working closely with cross-functional stakeholders to deliver project milestones. What you'll need to succeed • Proven experience within pharmaceutical, biotechnology or life sciences manufacturing environments. • Strong background in equipment qualification and validation. • Experience authoring and executing IQ, OQ and PQ protocols. • Thermal mapping experience across controlled temperature units. • Knowledge of GMP, EU GMP and validation life cycle requirements. • Experience managing deviations, investigations and CAPAs. • Ability to generate and review validation documentation independently. • Excellent communication, technical writing and organisational skills. Desirable experience: • New asset introduction projects. • Lyophiliser qualification. • Sterilisation validation. • Utilities qualification (HVAC, WFI, Purified Water, Clean Utilities). • Sterile manufacturing or aseptic processing environments. Must have Full Right to Work in the UK for duration of contract. No Sponsorship provided. What you'll get in return • Long-term contract opportunity. • Outside IR35 engagement. • Competitive day rate. • Opportunity to work on high-profile qualification and validation projects within a GMP manufacturing environment. • Collaborative project team and exposure to significant new asset introduction activities. What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.