A global pharmaceutical manufacturer is seeking a high-calibre Senior Commissioning & Qualification (CQ) Project Manager to lead client-side C&Q 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&Q 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&Q 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.
