CQV / Validation Engineer – Equipment Qualification (Outside IR35)

About the role

Join a leading pharmaceutical manufacturing organisation as a CQV / Validation Engineer. You will support new asset introduction and qualification activities within a GMP regulated environment, working closely with engineering, quality, manufacturing and project teams.

Key responsibilities

• Author, review and execute validation documentation including Validation Plans, Risk Assessments, IQ, OQ and PQ protocols, and Validation Summary Reports.
• Support new equipment introduction projects from planning through to GMP release.
• Execute qualification activities for manufacturing and laboratory equipment, including lyophilisers, sterilisers and associated utilities.
• Perform thermal mapping on controlled temperature units such as fridges, freezers and incubators.
• Conduct pre‑calibration and post‑calibration activities.
• Manage deviations, investigations, CAPAs and change controls.
• Analyse qualification data and produce technical reports.
• Collaborate with cross‑functional stakeholders to meet project milestones.

Required profile

• Proven experience in pharmaceutical, biotechnology or life‑science manufacturing environments.
• Strong background in equipment qualification and validation.
• Experience authoring and executing IQ, OQ and PQ protocols.
• Thermal mapping experience on controlled temperature units.
• Knowledge of GMP, EU GMP and validation life‑cycle requirements.
• Experience managing deviations, investigations and CAPAs.
• Full right to work in the UK for the contract duration.

Required skills

• Equipment qualification
• Validation (IQ/OQ/PQ)
• Thermal mapping
• GMP compliance
• EU GMP knowledge
• Deviation management
• CAPA handling
• Change control
• Technical report writing
• Data analysis

What we offer

• Long‑term contract opportunity outside IR35
• Competitive day rate
• Exposure to high‑profile qualification and validation projects in a GMP environment