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Project Engineer – Pharma Manufacturing

PCI Pharma Services · Stamullen

Nouveau
🇬🇧 English
cGMP EHS FAT SAT Technical drawing

Description du poste

About the role

PCI Pharma Services is seeking a Project Engineer to lead engineering initiatives across its manufacturing sites. The role focuses on specifying, developing, purchasing, and introducing new facilities, equipment, and tooling that meet both company and customer requirements.

Key responsibilities

  • Define specifications, develop designs and manage purchase of site facilities, production equipment, and tooling.
  • Coordinate and execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to ensure equipment fit‑for‑purpose.
  • Maintain technical documentation, including tooling logs, setting sheets, preventive‑maintenance schedules, and drawing databases.
  • Ensure all projects comply with statutory, regulatory, EHS, cGMP, and internal technical standards.
  • Drive projects to completion on time, within budget, and to agreed quality standards.
  • Support continuous‑improvement initiatives, OEE projects, and right‑first‑time culture.
  • Identify future capital investment opportunities and prepare site capital application requests.

Required profile

  • Proven experience in specification, development and procurement of manufacturing equipment and tooling.
  • Hands‑on experience coordinating FAT and SAT trials.
  • Familiarity with technical documentation practices and regulatory compliance in a pharma environment.
  • Ability to work safely, report near‑misses, and follow EHS procedures.

Required skills

  • cGMP compliance
  • EHS standards
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Technical drawing creation and maintenance
  • SOP development
  • Database management for tooling and drawings

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PCI Pharma Services

Stamullen