Role Overview
We are seeking an experienced CQV (Commissioning, Qualification & Validation) Lead to support a GMP manufacturing facility in Cork. The successful candidate will provide technical leadership and oversight for CQV activities, ensuring all systems, utilities, and equipment are commissioned and qualified in line with project timelines, industry standards, and regulatory requirements.
This is a 6-month contract role, ideally suited to a candidate with strong CQV leadership experience in GMP environments.
Key Responsibilities
- Lead the planning, coordination, and execution of CQV activities across assigned systems and equipment.
- Develop and review CQV deliverables, including protocols (IQ/OQ/PQ), test scripts, and summary reports.
- Ensure compliance with GMP, FDA, EMA, and ICH guidelines throughout all qualification and validation phases.
- Oversee contractor/vendor activities related to CQV execution.
- Manage deviations, change controls, and CAPAs arising from CQV execution.
- Interface with project engineering, quality, manufacturing, and automation teams to drive project progress.
- Support regulatory inspections and audits, providing CQV expertise and documentation as required.
- Ensure project milestones are met within scope, schedule, and budget.
- Mentor junior CQV engineers and provide technical guidance.
Qualifications & Experience
- Bachelor's degree (or higher) in Engineering, Science, or related discipline.
- 8+ years' experience in Commissioning, Qualification, and Validation within the pharmaceutical/biopharma industry.
- Proven track record in leading CQV activities for GMP facilities, including utilities, process equipment, and/or cleanrooms.
- Strong understanding of regulatory requirements (FDA, EMA, cGMP, ASTM E2500, ISPE guidelines).
- Experience managing cross-functional teams and external vendors/contractors.
- Excellent problem-solving, communication, and organizational skills.
- Ability to work independently while driving project deliverables under tight deadlines.
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