- A new opportunity has arisen for a Downstream Process Equipment Lead at our client’s biopharmaceutical facility in Co. Waterford.
- Reporting to the Process Equipment Project Manager, the Downstream Process Equipment Lead will take responsibility for the design coordination, specification, factory and site acceptance testing and qualification of various vendor equipment packages in the downstream mammalian cell-based bioprocessing suite.
Core Duties and Responsibilities:
- To lead a project team in the specification, testing, commissioning and qualification of downstream vendor packaged equipment including centrifuges, filtration skids, TCU’s, chromatography skids, eluate vessels, single-use mixers, laminar flow cabinets, bottle filling equipment, parts washers and autoclaves.
- To provide client-side upstream equipment SME input during downstream suite 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 suite and 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 downstream biomanufacturing environment.
- Biopharma plant start-up experience desirable.
- Experience in automation systems such as Delta-V.
- Previous experience in the specification/qualification/operation of the relevant equipment.
- 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 – PE22072
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.