We are seeking an experienced CQV API Project Lead to oversee a multi-discipline Commissioning & Qualification (C&Q) team delivering a large-scale API pharmaceutical facility project from design through to end-user handover. The successful candidate will provide leadership, technical oversight, and coordination across all C&Q lifecycle activities, ensuring safe, compliant, and high-quality delivery aligned with cGMP, ISPE, and ASTM E2500 standards.
This role requires a strong background in API pharmaceutical commissioning and qualification, with proven experience leading teams in complex capital projects within regulated environments.
Responsibilities
Lead and manage the site C&Q programme across the full project lifecycle (Design through to Handover)
Ensure all commissioning and qualification activities are executed in line with site procedures, cGMP, and industry best practices
Oversee development and execution of C&Q protocols including IQ/OQ activities
Plan, schedule, and coordinate vendor activities including FAT, SAT, and IOQ execution
Provide technical leadership and guidance to the C&Q team
Ensure safety oversight of all C&Q activities in collaboration with the project safety team
Manage change control processes throughout the project lifecycle
Develop and maintain C&Q schedules, tracking progress, forecasting, and reporting metrics
Produce summary reports, status updates, and performance metrics for stakeholders
Interface with engineering, quality, client representatives, and end users across all project phases
Lead and mentor C&Q team members, supporting capability development and delivery performance
Forecast resource and project needs, ensuring timely interventions to meet schedule requirements
Requirements
Degree or equivalent qualification in an engineering-related discipline
15+ years’ experience in commissioning and qualification within API pharmaceutical facilities
Proven experience leading and managing C&Q teams on large-scale pharma projects
Strong knowledge of ISPE guidelines and ASTM E2500 approach
Experience with KNEAT and DeltaV systems
Strong leadership, communication, and stakeholder management skills
Ability to work collaboratively across multi-discipline project teams in a regulated environment
Demonstrated experience in lifecycle C&Q delivery from design through to system handover
*Only candidates with a valid work visa for Ireland or an EU passport will be considered.
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