My client is a pharmaceutical manufacturer based in Carlow with a position available on their projects team for an experienced pharmaceutical Process Engineer with experience working on large projects. In this role you will be a part of a multi-discipline team, specifically responsible for assisting the lead in the cost, schedule and technical aspects of the project scope. As the successful candidate, you will be required to work closely with a cross-functional team and coordinate activities between Design, Construction, Process, Technical Operations, C&Q, IPT and QA. You will be responsible to provide process engineering services in support of the design, construction, commissioning and qualification of a Sterile Formulation and Filling Facility.
- Assist in the development and delivery, within the overall project schedule, of a schedule for the delivery of all aspects of the Suite scope.
- Provide support for the administration, within a project charter, of the project execution within the overall capital project budget and schedule.
- Coordinate the design effort with the contract engineering firm and ensure compliance to local & Global Standards.
- Support cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
- Monitor progress of process team milestones with all team members and provide status reports to project Tiers and stakeholders.
- Assist in the assurance that project utilities designs are safe, constructible, operable, maintainable, economical, and compliant with regulatory requirements and authorized project scope.
- Support Project team and C&Q team to coordinate preparation and lead FATs/C&Q field execution.
- Develop and/or review system lifecycle documents including Criticality and Risk assessments, FAT documentation, and C&Q documentation.
- Support installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
- Provide coordination expertise during C&Q activities as needed.
- Assist in the coordinating of C&Q start-up activities, punch list follow-up.
- Liaise with the various stakeholders on the overall project to ensure clear communication between all parties.
- Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.
- Coordinate third party vendors during SAT execution. Review and contribute to SAT protocols.
- Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
Qualifications & Experience:
- Degree qualified in Engineering or Science related discipline.
- 5+ years’ experience similar role in the Pharmaceutical industry such as Pharmaceutical Facility/ Building/Utilities systems.
- Experience of design and construction/handover of pharmaceutical process and building facilities for pharmaceutical facilities.
- Ability to work in design and construction large project environment within Ireland.
- Working knowledge of database management software’s and CAD software.
Job Types: Full-time, Contract