Support the delivery of capital and site-based projects within utilities and facilities infrastructure at a leading pharmaceutical manufacturing site in Co. Kildare. The role will focus on projects involving clean utilities, plant utilities, and facility support systems within a highly regulated GMP environment.The Project Engineer will contribute to the planning, coordination, and execution of modifications, upgrades, and new installations to ensure utilities, equipment, and facility systems operate safely, reliably, and in compliance with GMP, FDA, and internal quality standards.Key ResponsibilitiesProject Delivery & CoordinationSupport the delivery of utilities and facilities projects from concept and detailed design through installation, commissioning, and final handover.Assist with upgrades, modifications, and expansions to site utilities including WFI, Purified Water, Clean Steam, HVAC, compressed air, process gases, chilled water, and supporting plant infrastructure.Support projects involving facility and building services equipment such as HVAC systems, chillers, pumps, vessels, skid-mounted systems, and mechanical utilities infrastructure.Coordinate project activities with Engineering, Facilities, Operations, Quality, Automation, and external vendors to ensure project milestones and deliverables are achieved.Assist in managing project scope, schedules, and contractor activities to support successful project execution.Documentation & GMP CompliancePrepare, review, and maintain project documentation including URS, design specifications, commissioning plans, test protocols, and project handover documentation.Ensure project activities are executed in accordance with GMP, FDA, and internal quality and engineering standards.Participate in risk assessments, change control processes, and impact assessments throughout the project lifecycle.Support site audit and inspection readiness by ensuring documentation is accurate and compliant.Support commissioning and start-up activities for utilities, facilities systems, and process support equipment.Execute commissioning and functional testing protocols and document system performance results.Assist with troubleshooting issues encountered during commissioning, qualification, and early operational phases in collaboration with vendors and site SMEs.Support deviation investigations, punch-list closeout, and the transition of completed systems to operations and maintenance teams.Experience & Qualifications3–7 years’ engineering experience within a GMP-regulated pharmaceutical, biotech, or life sciences manufacturing environment.Level 8 degree in Engineering, Mechanical, Electrical, Process, Chemical, or related engineering discipline.Experience supporting utilities, facilities, or process support systems such as WFI, Purified Water, Clean Steam, HVAC, compressed air, chilled water, or CIP systems.Understanding of engineering project lifecycle phases including requirements definition, design coordination, installation, commissioning, and system handover.Experience preparing and maintaining technical and GMP documentation including URS, test plans, commissioning reports, and as-built documentation.Exposure to validation, qualification, and investigation processes is advantageous.Strong organisational skills with the ability to manage multiple project workstreams and priorities.Practical, hands‑on approach to engineering problem solving, particularly during commissioning and start‑up phases.Good understanding of GMP and FDA regulatory requirements relating to utilities and manufacturing infrastructure.Strong communication skills with the ability to work cross‑functionally with Engineering, Facilities, Manufacturing, Quality, and external contractors.High attention to detail with a strong focus on safety, compliance, and quality.Ability to work independently while contributing effectively within a multidisciplinary project team.
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