- A new opportunity has arisen for an Upstream Process Equipment Lead at our client’s biopharmaceutical facility in Co. Waterford.
- Reporting to the Process Equipment Project Manager, the Upstream 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 upstream mammalian cell-based bioprocessing suite.
Core Duties and Responsibilities:
- To lead a project team in the specification, testing, commissioning and qualification of upstream vendor packaged equipment including rocker bioreactors, single use bioreactors, centrifuges, TCU’s, filtration skids, cell bank storage and bio-safety cabinets.
- To provide client-side upstream equipment SME input during inoculation/upstream 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 upstream large-scale biomanufacturing environment.
- Biopharma plant start-up experience desirable.
- Experience in automation systems such as Delta-V.
- Previous experience in the specification/qualification/operation of single-use bioreactors, Centrifuges, wave bag technology.
- 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 – PE22071
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.