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CQV Manager

Posted 1 day 4 hours ago by Morgan McKinley

Permanent
Full Time
Other
Leinster, Ireland
Job Description

A global pharmaceutical manufacturer is seeking a high-calibre Senior Commissioning & Qualification (CQ) Project Manager to lead client-side C&AQ delivery for a major brownfield retrofit project. The scope encompasses new cleanroom construction, HVAC, MEP utilities, and state-of-the-art process equipment for an Oral Solid Dose manufacturing facility.

Key Responsibilities
  • CQV Strategy & Ownership: Develop and drive the site-wide Commissioning, Qualification, and Validation strategy (through to PQ) in compliance with GMP, GEP, and risk-based verification standards.
  • Client-Side Leadership: Serve as the single point of contact for CQV; manage internal client resources, equipment vendors, and third-party Commissioning Partners to ensure schedule, safety, and quality alignment.
  • Turnover & Transition Management: Oversee the seamless handover of systems from Mechanical Completion (MC) through C&AQ to Operations, ensuring full closure of punch lists and deviations.
  • Cross-Functional Collaboration: Interface directly with Design, Construction, Quality, EHS, Manufacturing, and Operational Readiness teams to resolve technical issues and manage risk.
  • Governance & Reporting: Drive resource planning, track milestones, and provide regular CQV status and risk reporting to senior leadership.
Essential Requirements
  • Experience: Minimum 12 years of pharmaceutical project experience, with a proven track record of leading C&AQ execution on large-scale facility/utility/equipment build-outs.
  • Technical Expertise: Deep knowledge of the validation lifecycle, CSV fundamentals, and regulatory expectations for cleanrooms, HVAC, process equipment, and utilities distribution.
  • Leadership: Demonstrated client-side (or client-representative) experience managing external commissioning partners, contractors, and multi-disciplinary internal teams.
  • Education: Degree in Engineering, Life Sciences, or a related technical discipline.
  • Skills: Excellent stakeholder management, risk mitigation, and communication skills under fast-track project conditions.
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