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
Only candidates based in UK and eligible to work in UK are allowed