Role Title: Senior Commissioning & Qualification Project Lead
Location: Athlone, Ireland
Role Type: Contract
Duration: 12 months initially with intent to extend - long term portfolio
Flexibility: Not initially - potential for 1 day/wk remote but would need review/discussion
Reporting Line: Senior Project Manager/Director
Overview
The organisation is undertaking a major expansion program to support the retrofit of a brownfield site to produce oral medicines. This role is part of the Athlone Expansions team and will support the delivery of capacity expansion projects on site.
Role Summary
Senior Commissioning & Qualification Project Lead responsible for developing, leading and providing oversight to the commissioning and qualification activities on a major retrofit of an OSD pharmaceutical facility. The project includes construction of new cleanrooms, HVAC, utilities, electrical, and installation of process equipment. The role is client-side, reporting to the Senior Project Manager/Director, and will be accountable for commissioning strategy, schedule, quality, safety, and compliance during the commissioning & qualification phase of the project. Candidates must have minimum 12 years' experience in pharma commissioning, proven management of commissioning partners and contractors as well as strong understanding of science and risk-based verification of facilities, utilities and process equipment.
Key Responsibilities
- 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.
Essential Requirements
Experience and Education:
- Degree qualification in Engineering, Science, related discipline or relevant experience
- Relevant experience in pharmaceutical and GMP regulated manufacturing environments
Knowledge:
- 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 Commissioning partners and internal CQV teams
- Demonstrated ability to manage interfaces with design and construction teams
- Experience planning and delivering complex commissioning and qualification programmes with multiple work packages and discipline leads
- Excellent stakeholder management and reporting skills; able to present to senior leadership and governance forums
Desirable Criteria (Optional)
Key Competencies
- Leadership of client teams
- Strong problem solving and decision-making under programme pressure
- Strong advocate and understanding of health & safety
- Strong communication skills across various levels of the organisation
- Detailed understanding of commissioning and qualification best practice for pharma facilities
- Strong documentation discipline and attention to detail; quality-focused
