Ref. 01326
Senior Process Engineer
Exciting opportunity for a Senior Process Engineer with our client, a leading pharmaceutical company based in Galway.
Summary
Reporting to the Associate Director or to the Director of Engineering, this role is responsible for providing process engineering services in support of upgrade projects in an existing Sterile Filling Facility. The successful candidate will join the Process Engineering Team and serve as the Package Owner and Vendor Point of Contact for new process equipment and upgrades to existing process equipment.
Responsibilities
Act as Package owner for new process equipment and upgrades to existing process equipment.
Manage vendor(s) for critical equipment detailed design, fabrication, installation on site and delivery up to PQ completion.
Develop Process Flow Diagrams, P&ID, User Requirement Specifications and Equipment Specifications to ensure Process Descriptions/Needs are met.
Facilitate team to complete process safety deliverables including PHA (Hazops).
Ensure all project stakeholders are consulted on key process suite activities.
Support C&Q Lead to coordinate preparation and C&Q field execution.
Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
May also be required to undertake Project Engineering duties including preparation of project related deliverables such as schedules, work plans, or equipment cost tracking.
Requirements
B. Sc. or M. Sc./ M. Eng Degree in Chemical or Biochemical Engineering or equivalent discipline.
5+ years post academic process engineering experience. Aseptic/sterile processing design, construction & start-up experience is preferred.
Strong understanding of process engineering and technologies pertinent to formulation and filling unit operations.
Knowledge of SDLC methodology.
Excellent communication/presentation/organizational skills.
