CQV Engineer – Biopharmaceutical GMP

UK & EU Projects | Biologics Manufacturing | GMP

We are seeking an experienced CQV Engineer to support equipment qualification and validation activities within GMP-regulated biopharmaceutical manufacturing environments.

This is a hands‑on role focused on delivering compliant, phase‑appropriate equipment lifecycle qualification across biologics production facilities.

If you have strong DQ/IQ/OQ/PQ experience and thrive in fast‑paced GMP environments, this is a high‑impact opportunity.

You will lead and execute commissioning, qualification and validation activities across equipment and facility systems within biologics manufacturing programmes.

Key responsibilities include:

• Preparing, executing and reviewing validation protocols and reports
• Supporting URS development and vendor assessments
• Coordinating and participating in FAT/SAT activities
• Applying risk‑based validation principles (ASTM E2500, ISPE GAMP 5 where applicable)
• Contributing to Validation Master Plans (VMPs) and impact assessments
• Managing deviations, investigations and CAPA activities
• Preparing validation documentation for regulatory inspections
• Supporting re‑qualification following facility upgrades or equipment modifications

This is a collaborative role working closely with QA, Engineering, Manufacturing and QC teams.

You will bring:

• Strong hands‑on CQV experience within GMP biopharmaceutical environments
• Demonstrated delivery of DQ/IQ/OQ/PQ activities
• Experience with in biologics manufacturing facilities
• Solid understanding of EU GMP, FDA and ICH expectations
• Confidence operating within multidisciplinary project teams
• Experience supporting inspections or audit readiness (desirable)

You should be comfortable operating independently while maintaining strict compliance standards.

• Exposure to complex biologics manufacturing environments
• Involvement in facility builds, upgrades and operational validation
• High‑visibility work within regulated GMP settings
• Opportunity to broaden your experience across multiple development phases

This role would suit a Validation Engineer, CQV Engineer or Senior Validation Specialist seeking broader exposure across biopharmaceutical programmes.