Role Summary:
- A new opportunity has arisen for an experienced Project Engineer – Automation to support our client’s team at their pharmaceutical site in Co. Waterford.
- The successful candidate will be responsible for delivering automation and equipment upgrade projects within a regulated biopharmaceutical environment.
- This includes ownership of multiple Lyo, CLU, PMS, Autoclave, and control‑system upgrade packages across several phases.
- The engineer will coordinate OEMs, ITS, Automation, Validation, and Quality teams to ensure compliant, right‑first‑time execution.
Core Duties and Responsibilities:
General Project Delivery
- Manage end‑to‑end delivery of automation and equipment upgrade projects (schedule, cost, scope, safety, quality, compliance).
- Coordinate OEMs, ITS, Automation, Validation, and Quality for multi‑phase deployments.
- Lead FAT/SAT activities, documentation, change controls, and qualification support.
- Ensure servers, control systems, and infrastructure are prepared, validated, and deployed correctly.
- Track change control actions to closure and maintain project governance.
- Manage line time, shutdown planning, and deployment coordination.
- Provide weekly progress updates to stakeholders.
Automation & Lyo‑Related Project Packages (Shortened)
- The role will support multiple automation and equipment upgrade projects across Lyo, CLU, PMS, Autoclave, and control‑system platforms.
- Key responsibilities include coordinating OEMs, ITS, Automation, Validation, and Quality teams; managing multi‑phase deployments; ensuring servers and control systems are prepared and validated; supporting FAT/SAT activities; and tracking change controls to closure.
Key project areas include:
- Lyo / CLU SCADA Lifecycle Management – Multi‑phase SCADA and server upgrades with ORISE (CIM).
- Lyo Shelf Stack Safety Interlock Upgrades – Safety interlock enhancements with IMA and SUIR.
- Line 2 PMS Upgrade – Virtual server and system upgrade with PMS.
- Autoclave 3 Deep Revamp – Control‑system and server upgrade with Getinge.
- Servers & Control System Revamp – Multi‑phase historian, UMS, and Lyo server upgrades with ORISE.
- Lyo Observation Upgrades (Line 1 & Line 2) – IPC and control‑system upgrades with Syntegon.
- RAMEN ID Analyser – Support as required.
Minimum Qualifications and Experience:
- Degree in Process, Mechanical, Chemical, Industrial, or related Engineering discipline.
- 5+ years’ experience delivering automation or equipment projects in pharmaceutical/biotech GMP environments.
- Strong understanding of GMP/GDP, validation lifecycle, cleanroom standards, and aseptic processing.
- Experience with OEM coordination, server upgrades, control‑system deployments, and CQV activities.
- Strong project planning, scheduling, budgeting, and risk management skills.
- Ability to manage multi‑phase, multi‑stakeholder projects.
- Proficiency in MS Office and project management tools.
Please note, we do not require agency assistance with this role.