Website Asset Recruitment
3 new vacancies have arisen to join our client’s state-of-the-art biologics manufacturing facility based in Meath. This site will play an important role as the Company’s first Biologics Drug Substance single use commercialization facility. Construction is currently underway and the facility is expected to be fully operational by 2023.
The Utility Engineer will support the operation readiness plan for the start-up of the plant engineering activities. They will also ensure that the activities and programs are delivered for start-up operations of the site Utilities.
• Be responsible for adherence to site and corporate QMS for Utility Systems
• Support audits, investigations, deviations and corrective actions for clean utility systems.
• Point of contact for Quality Alerts and Bulletins for Utility Systems. Review and prepare formal responses.
• Author, Review and approve all Utility Systems startups, change requests, and SOP’s.
• Support lead factory acceptances and site acceptance trials, FATs and SATs
• Represent the Utilities engineering group and lead highly technical cross-functional teams and work across utilities engineering areas to deliver robust and sustainable solutions and business processes.
• The primary focus of the position is on GMP and black utilities and operations (WFI, Purified Water, Clean Steam, Reverse Osmosis, Process Gasses, and HVAC systems, CTU systems, Electrical systems, automation systems)
• Consult with other subject matter experts to ensure design solutions achieve long term business objectives and are supported by robust technical rationale to withstand scrutiny.
• Act as the utilities engineering expert and technical consultant to management in identifying opportunities, prioritizing work and will make sound recommendations for design and construction solutions.
• Support and lead the handover of targeted utility systems from the projects /build team to the sustaining operations and maintenance team
• Provide support to the reliability team in areas such as FMECA, Criticality Assessments, Predictive instrumentation deployment
• 3rd Level Qualification in Engineering (Electrical, Mechanical, Process)
• 5+ years experience in a similar role within the pharma/biotech sector
• Experience with FAT, SAT, Equipment walkdowns, post IQ OQ Transfer of responsibility
• Demonstrated capability of understanding EHS & GMP compliance requirements (particularly from an Engineering perspective)
• Demonstrated capability within the Audit environment (specifically EHS & GMP)
• Ability to prepare budgets and tightly control expenditures
• Strong knowledge of industrial safety standards.
• Demonstrated understanding of Project life Cycle, from design through to commissioning/qualification & retirement
• Ability to effectively transfer knowledge from a project environment to a sustain environment