CQV Lead

CAI • Limerick, PA

2d • Onsite

About The Position

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.

Requirements

• 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.
• Eligible to work in the EU without the need for visa sponsorship, now or in the future.

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 This Job Offers

• Job Type: Full-time
• Career Level: Senior