CQV Lead

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

We are seeking an experienced CQV Lead to drive qualification and validation activities for a broad range of laboratory and benchtop equipment within a GMP-regulated environment. This position offers the opportunity to lead critical qualification projects, work closely with Quality, Engineering, Validation, and Laboratory teams, and play a key role in supporting both operational excellence and regulatory compliance.

The successful candidate will provide technical leadership across the full equipment lifecycle, from installation and qualification through ongoing compliance and continuous improvement initiatives.

Key Responsibilities

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

What We're Looking For

• Degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline.
• Experience leading CQV or validation activities within pharmaceutical, biotechnology, or medical device manufacturing.
• Strong knowledge of GMP requirements and qualification lifecycle principles.
• Hands-on experience qualifying laboratory and benchtop equipment such as:
  • HPLC, UPLC and chromatography systems
  • TOC analyzers
  • UV-Vis spectrophotometers
  • Autoclaves and sterilization equipment
  • Incubators and environmental chambers
  • Balances and weighing systems
  • Freezers, refrigerators and stability chambers
  • Particle counters and laboratory instrumentation
• Experience authoring and reviewing qualification protocols and reports.
• Strong stakeholder management and project leadership skills.
• Excellent communication and problem-solving abilities.

Other Requirements

• This is a site based role
• Eligible to work in the EU without the need for visa sponsorship, now or in the future.

What Success Looks Like

You will be the go-to CQV subject matter expert for laboratory equipment qualification, ensuring projects are delivered on schedule while maintaining the highest standards of quality, compliance, and inspection readiness.

Why CAI?

At CAI, our people are at the heart of everything we do. We partner with the world's leading life sciences companies to deliver innovative projects that ultimately improve patient lives. You'll work alongside industry leading experts in a collaborative environment that supports professional growth and technical excellence.

If you're a CQV professional looking to contribute to a challenging pharmaceutical project while developing your career with a global consultancy, we'd love to hear from you.