Role Overview
- Location: Athlone, Ireland
- Team: Process Engineering / Capital Projects
- Equipment Scope: Upstream/Downstream processing, Fill-Finish, Washers, and Sterilisers.
Key Responsibilities
1. Equipment Lifecycle Management
- User Requirement Specifications (URS): Translate operational needs into technical documents that tell vendors exactly what the machine must do.
- Vendor Liaison: Act as the daily point of contact for equipment manufacturers (OEMs), managing technical queries and schedule updates.
- Design Review: Lead 3D model reviews and P&ID walkthroughs for specific equipment skids to ensure they fit the space and meet Novo Nordisk standards.
2. Factory & Site Testing
- FAT/SAT Leadership: Travel to vendor sites globally to lead Factory Acceptance Testing (FAT), ensuring the equipment works before it ships to Athlone.
- Installation Support: Supervise the physical "rigging" and positioning of equipment on-site, ensuring utilities (provided by the HVAC/Utilities Lead) are correctly connected.
3. Commissioning & Validation (C&Q)
- Protocol Execution: Write and execute the IQ (Installation Qualification) and OQ (Operational Qualification) scripts.
- Troubleshooting: Identify and resolve "snags" or mechanical failures during the initial water-runs and media-fills.
The Process Equipment Landscape
Equipment Type
Typical Systems Involved
Upstream
Bioreactors, Media Prep tanks, Centrifuges.
Downstream
Chromatography columns, Ultrafiltration (UF/DF) skids.
Fill-Finish
Vials/Syringe filling lines, Lyophilizers (Freeze-dryers).
Support
Autoclaves, Parts Washers, CIP (Clean-in-Place) stations.
Candidate Profile
- Experience: 3-7 years in a highly regulated manufacturing environment (Pharma/Bio-Pharma is essential).
- Technical Skills: Strong understanding of stainless steel fabrication, pressure vessels, and automated control systems (DeltaV/PLC).
- Mindset: Highly organized with a "finisher" mentality-someone who enjoys seeing a machine go from a drawing to a humming piece of production kit.
Education: B.Eng in Mechanical, Chemical, or Biomedical Engineering
