Hays
CQV / Validation Engineer (Equipment Qualification) OutsideIR35
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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.
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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.
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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.
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