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Project Engineer – Pharmaceutical Manufacturing

Morgan McKinley · Tralee

🇬🇧 English
cGMP validation URS FDS FAT SAT IQ/OQ Risk assessment

Job description

About the role

Join a leading global pharmaceutical manufacturer focused on sustainability and societal well‑being. Reporting to the Engineering Projects & Systems Lead, you will own the full lifecycle of CAPEX and non‑CAPEX projects, from concept through handover, while driving cross‑functional collaboration.

Key responsibilities

  • Lead end‑to‑end delivery of engineering projects, including feasibility studies, goal setting, scheduling and resource coordination.
  • Maintain full financial accountability for project cash flow and budgets.
  • Motivate and guide internal teams and external vendors to achieve project milestones.
  • Generate and execute cGMP validation and lifecycle documentation (URS, FDS, FAT, SAT, IQ/OQ, risk assessments).
  • Maintain MES‑controlled documents, system configurations and descriptions.
  • Ensure controlled handovers to business units and conduct post‑project reviews for continuous improvement.

Required profile

  • Proven project engineering/management or validation experience in a pharmaceutical manufacturing environment.
  • Track record of delivering equipment and engineering projects on time and within budget.
  • Strong financial acumen related to engineering project performance.
  • Deep understanding of the project lifecycle from concept through qualification.
  • Excellent communication, analytical problem‑solving and time‑management skills.
  • Preferred: direct experience in drug manufacturing and experience in a cGMP start‑up environment.

Required skills

  • cGMP validation
  • MES document control
  • URS, FDS, FAT, SAT documentation
  • IQ/OQ protocols
  • Risk assessment methodology

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Published 2 months ago

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Morgan McKinley

Tralee