Process Engineer | Biopharmaceutical Plant | Limerick, Ireland
Role Overview:
Operate as an integral member of the cross-functional site team, responsible for driving process start-up activities for the project as a PSQ/Process Engineer. Support the scheduling and delivery of the full PSQ programme, in close alignment with the PSQ Project Manager and wider project timelines.
Key Responsibilities:
- Support the development, scheduling, and delivery of the full PSQ programme, ensuring alignment with project management and milestones.
- Coordinate and liaise directly with the Global Facilities Delivery (GFD) Commissioning and Qualification Team to secure the safe and timely handover of utilities and equipment to the site process team.
- Define Performance Qualification (PQ) study requirements and author detailed PQ protocols to prepare manufacturing equipment for production initiation.
- Play a key role in PQ schedule development by defining equipment groupings, sequencing logic, and estimating durations for all required PQ activities.
- Participating actively in site meetings and activities.
Qualifications & Skills:
- Bachelor’s degree in Engineering or Science (BSc/BE) or equivalent practical experience required.
- Minimum of 5 years’ experience in commissioning and qualification of pharmaceutical equipment and utilities, ideally within a site start-up environment.
- Demonstrated proficiency with MS Project for scheduling and programme management.
- In-depth knowledge of GMP regulations, relevant regulatory requirements, and best practices for equipment commissioning and qualification.
- Experience with systems such as DeltaV (batch processing), Syncade MES, Kneat validation management, or SAP is highly advantageous.
- Strong written and verbal communication skills with the ability to engage effectively with both technical and non-technical stakeholders.