Senior CQV Lead, Lab Equipment Validation

Caiready; Limerick; Hybrid; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

CAI is seeking an experienced CQV Lead to drive qualification and validation activities for laboratory and benchtop equipment within a GMP environment in Ireland. You will lead cross-functional teams across Quality, Engineering, Validation and Laboratory functions to ensure on-time delivery and regulatory readiness.

The role covers IQ/OQ/PQ documentation, lifecycle management, deviations and CAPAs, with hands-on oversight of equipment like HPLC systems, TOC analyzers, UV-Vis spectrophotometers,

Qualifikationen

• Degree in Engineering, Life Sciences, Biotechnology, or related discipline.
• Experience leading CQV or validation activities within pharma, biotech, or medical device manufacturing.
• Strong GMP knowledge and qualification lifecycle principles.

Aufgaben

• Lead commissioning, qualification, and validation activities for laboratory and benchtop equipment within GMP environments.
• Develop and execute IQ, OQ, PQ protocols and final reports.
• Support introduction of new laboratory equipment and technologies, ensuring compliance with 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 validated through periodic reviews, requalification, 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.

Kenntnisse

CQV leadership

GMP knowledge

Project leadership

Stakeholder management

Qualification lifecycle

Ausbildung

Engineering degree or life sciences

Tools

HPLC/UPLC systems

TOC analyzers

UV-Vis spectrophotometers

Autoclaves

Incubators/environmental chambers

Balances/weighing systems

Freezers/refrigerators/stability chambers

Particle counters

Jobbeschreibung

CAI is seeking an experienced CQV Lead to drive qualification and validation activities for laboratory and benchtop equipment within a GMP environment in Ireland. You will lead cross-functional teams across Quality, Engineering, Validation and Laboratory functions to ensure on-time delivery and regulatory readiness.

The role covers IQ/OQ/PQ documentation, lifecycle management, deviations and CAPAs, with hands-on oversight of equipment like HPLC systems, TOC analyzers, UV-Vis spectrophotometers,