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Sean McCarthy
Life Science

+3530212339371
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Details

CAPEX API Project Manager


Reference:SMC92849 Location: Tipperary
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: BD Manager, Project Lead, Project Manager

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.

Education and Experience
  • 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
If interested in this posting, please contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.