CQV Lead: GMP Lab Equipment Qualification

CAI; Limerick; On-site; EUR 85,000 - 120,000; Full time

Job summary

CAI is seeking an experienced CQV Lead to drive qualification and validation activities for laboratory and benchtop equipment within GMP environments. You will lead projects across QA, Engineering, Validation and Laboratory teams, ensuring regulatory compliance and operational excellence.

You will provide technical leadership across the equipment lifecycle, from IQ/OQ/PQ through ongoing requalification and lifecycle management, mentoring CQV engineers and supporting audits and inspections.

Qualifications

• CQV or validation experience in pharma/biotech/med‑device manufacturing.
• Experience with GMP requirements and qualification lifecycles.
• Experience authoring/ reviewing qualification protocols and reports.

Responsibilities

• Lead commissioning, qualification, and validation activities for lab and benchtop equipment within GMP environments.
• Develop and execute IQ, OQ, PQ protocols and final reports.
• Support introduction of new equipment ensuring compliance with procedures and regulations.
• Coordinate qualification activities with Quality, Operations, Lab, Engineering, and vendors.
• Manage deviations, change controls, CAPAs, and investigations for qualified equipment.
• Ensure equipment remains validated through reviews, requalification, lifecycle management.
• Provide technical guidance to CQV engineers and validation team members.
• Support internal and external audits and regulatory inspections.
• Identify and implement process improvements to enhance efficiency and compliance.

Skills

Stakeholder management

Project leadership

Communication

Problem solving

Education

Engineering or Life Sciences degree

Tools

HPLC/UPLC systems

TOC analyzers

UV-Vis spectrophotometers

Autoclaves

Incubators/Environmental chambers

Balances/Weighing systems

Freezers/Refrigerators/Stability chambers

Particle counters

Job description

CAI is seeking an experienced CQV Lead to drive qualification and validation activities for laboratory and benchtop equipment within GMP environments. You will lead projects across QA, Engineering, Validation and Laboratory teams, ensuring regulatory compliance and operational excellence.

You will provide technical leadership across the equipment lifecycle, from IQ/OQ/PQ through ongoing requalification and lifecycle management, mentoring CQV engineers and supporting audits and inspections.