- A new opportunity has arisen for a Process Utilities Equipment Lead at our client’s biopharmaceutical facility in Co. Waterford.
- Reporting to the Process Equipment Project Manager, the Process Utilities Equipment Lead will take responsibility for the design coordination, specification, factory and site acceptance testing and qualification of various utility equipment packages supporting the drug substance bioprocessing suites.
Core Duties and Responsibilities:
- To lead a project team in the specification, testing, commissioning and qualification of various vendor and stick build process utility packages such as Pure Steam Generators, WFI Stills/ Pre-treatment, WFI Storage & Distribution Systems, Process Gasses, CIP skids & distribution systems and Process Waste systems.
- To provide client-side equipment SME input during detailed design, P&ID development, URS development and vendor package technical reviews.
- To ensure schedule adherence and cost control across the various equipment packages, and to provide regular updates to the Project Manager.
- To lead equipment package FAT’s, SAT’s and CQV activities.
- To provide SME support for on-site vendor and contractor activities related to equipment installation, commissioning and qualification.
Qualifications and Experience:
- Bachelor’s Degree in a related science or engineering discipline.
- At least 10 years relevant experience, at least 5 of which in a similar large-scale biomanufacturing environment.
- Biopharma plant start-up experience desirable.
- Experience in PLC systems and integration with control systems such as Delta-V.
- Previous experience in the specification/qualification/operation of some or all of the equipment packages listed above. Previous experience with Parts Washers/Autoclaves an advantage.
- Previous experience in leading the full life-cycle equipment introduction process – from URS development and design document reviews, to FAT, SAT, commissioning, IQ/OQ planning/execution, and supporting PPQ/operational readiness.
- Experience in leading project teams to ensure appropriate EHS, Validation, Technical Services, Quality and Manufacturing resources are identified and managed as required throughout the equipment package life cycles.
- Experience coordinating and problem solving cross-functionally with the wider Quality, Operations, Validation, EHS and Technical Operations stakeholders.
To Apply: Quote – PE22070
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.