Process Support Qualification Engineer (PSQ) required for Life Sciences client based in Limerick. Initial 12 month contract. Engineering support required for PQ strategy development activities, including bill of materials definition for PQ studies, consumables requirements, sampling requirements, authoring PQ strategies and protocols.
Responsibilities
The PSQ Eng will be working as part of a cross functional team on site delivering the process start up
Support in scheduling & delivery of the PSQ Programme
Co-ordination & interaction with the Global Facilities delivery (GFD) Commissioning and Qualification Team for safe, on-time transition of utilities & equipment to the site process team.
Maintaining PSQ Schedule with the PSQ PM.
Define PQ study requirements and author PQ protocols to prepare production equipment to support manufacturing activities.
Input to PQ schedule development – defining equipment groups, logic, and duration for required PQ studies.
Responsible, with input from relevant SMEs, for developing detailed bill of materials for PQ studies based on family groupings / bracketing approach, including consumables and raw materials components for PQ studies.
Responsible for applying the PQ strategy and developing a sampling matrix to support the studies.
Involvement in the implementation of paperless PQ protocol execution solution.
Execute PQ protocols during PQ execution phase. Troubleshoot issues encountered during PQ protocol execution, write and attain approval for discrepancies, implement solutions to ensure a robust PQ program.
Support process teams in preparing for manufacturing and participate in required process engineering team meetings.
Role Requirements
BS Engineering or Science (or equivalent experience)
Minimum 5 years project experience in the commissioning and qualification of pharma equipment and utilities preferably during start-up activities.
Proficient with MS Project
Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification
Self-motivated, proactive approach with a commitment to meet deadlines
Good written and verbal communication skills with both technical and non-technical staff.
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