Senior Commissioning & Qualification Lead

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Athlone. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Develop and own the Commissioning, Qualification & Validation (CQV) strategy and execution plan for the project, aligned to project schedule and GMP requirements up to Performance Qualification of all systems and equipment. Act as Client C&Q Lead onsite throughout execution; coordinate all commissioning and qualification activities and act as single point of contact for CQV interfaces.
• Plan and lead execution of system commissioning and qualification of HVAC, cleanrooms, process utilities, process equipment, utilities distribution systems, automation/controls and laboratory equipment in accordance with project schedule and phased release of areas.
• Oversee and coordinate Commissioning Partner and commissioning sub-contractors; manage performance against scope and programme. Commissioning partner responsible for commissioning of utility and facility systems.
• Management and coordination of internal client team including Work Package Owner and CQV resources as well as equipment vendor. Client team responsible for qualification of facility and utilities (up to PQ) and for process equipment the internal client team is responsible for commissioning through to PQ.
• Interface with internal stakeholders including Quality, Manufacturing, Operational Readiness, Engineering, EHS, QC.
• Strong knowledge of GMP, validation lifecycle, CSV (computer system validation) fundamentals, and regulatory expectations for qualification documentation
• Provide regular CQV status reporting (commissioning progress, qualification status, open actions, risks) to the Senior Project Manager and governance forums.
• Manage interface between design team, construction, CQV (Commissioning, Qualification & Validation) and operations to ensure smooth transition from Mechanical Completion (MC) to Commissioning & Qualification (C&Q).
• Drive risk management: identify, evaluate and mitigate risks; maintain and report risk registers.
• Collaboration during turnover activities and ensure successful system handover to CQV and Operations including documentation, training and punchlist closure.
• Ensure best-practice quality management and documentation for GMP and GEP compliance(CTOP, VTOP, test packs, deviation reports).
• Drive resource planning and site resourcing to meet programme and milestones.
• Drive resolution of CQV issues, deviations, and change controls

• Degree qualification in Engineering, Science, related discipline or relevant experience
• Minimum 12 years’ project management experience, with demonstrable experience in pharmaceutical projects.
• Proven track record of leading commissioning and qualification phase of large projects involving cleanrooms, HVAC, MEP, utilities and process equipment installation.
• Client-side experience or acting as client representative is a major benefit
• Strong experience managing Commissiong partners and internal CQV teams
• Experience planning and delivering complex commissioning and qualification programmes with multiple work packages and discipline leads.