We’re currently recruiting for a CAPEX API Project Manger to support a major pharmaceutical manufacturer based in Ballydine, Co. Tipperary.

This is a contract opportunity working on the delivery of API facility scope through design, construction, commissioning and qualification. The role will suit an experienced pharmaceutical project professional who has worked across large-scale GMP capital projects, ideally within API, drug substance, chemical synthesis or complex process manufacturing environments.

Duties

• Coordinate delivery of API facility project scope through to commissioning and qualification.
• Lead the development, monitoring and execution of project plans across design, construction, commissioning and qualification.
• Manage project schedule, cost, safety, quality and performance in collaboration with suite leads, senior project team members, operations and external partners.
• Coordinate design input with the contract engineering firm and ensure alignment with site and global standards.
• Facilitate engineering and user requirements for project suites.
• Track progress against key deliverables and report project status as required.
• Lead coordinated owner-side reviews of layouts, P&IDs, AF&IDs, process descriptions, specifications, change controls, purchase orders and datasheets.
• Support the development of construction, procurement, C&Q and project control strategies.
• Maintain a strong safety culture throughout project execution.
• Lead and attend daily communication meetings with suite teams as required.

• Bachelor’s degree in Engineering, Science, Technology or related discipline.
• Minimum 10 years’ relevant experience in pharmaceutical project management.
• Significant API project experience is strongly preferred. Oil & Gas will be considered.
• Strong understanding of GMP project delivery and quality systems.
• Working knowledge of FDA and EU regulatory expectations preferred.
• Experience with API unit operations and large-scale process equipment.
• Strong understanding of commissioning and qualification documentation for cGMP process equipment.
• Working knowledge of process control systems and automation.
• DeltaV and BMS experience would be beneficial.
• Ability to lead cross-functional teams and manage project stakeholders effectively