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SENIOR PROCESS EQUIPMENT LEAD – DOWNSTREAM
An exciting new long term contract opportunity has arisen for an experienced Senior Process Equipment Lead – Downstream who will be required to take responsibility for all design coordination, specification, FATs/SATs, testing and qualification of vendor equipment packages within the downstream mammalian cell-based bioprocessing suite. Reporting to the Process Equipment Project Manager this is a key role in this major biopharmaceutical construction project.
- Providing Client-Side Downstream Equipment Subject Matter Expertise input during Downstream Suite Detailed Design, P&ID Development, URS development and Vendor Package Technical Reviews.
- Lead Project Team in Specification, Testing and CQV Of Downstream Vendor Packaged Equipment Including Chromatography, Centrifuges and Filtration Skids, TCU’s, Eluate Vessels, Single-Use Mixers, Laminar Flow Cabinets, Parts Washers and Autoclaves and Bottle Filling Equipment.
- Ensure Schedule Adherence and Cost Control across Equipment Packages and provide regular updates to Project Manager.
- Lead Equipment Package FAT’s, SAT’s and CQV activities.
- Provide SME support for on-site vendor and contractor activities related to suite and Equipment Installation and CQV.
EXPERIENCE & QUALIFICATIONS
- 10+ years Biopharma Projects experience.
- 5+ years’ experience in Large-Scale Downstream Biopharma Manufacturing environment.
- Biopharma plant start-up experience desirable.
- Experienced in Automation Systems such as Delta-V.
- Experienced in Specification, Qualification, operation of relevant Equipment.
- Previous experience in Leading 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 Equipment Package Life Cycles.
- Experience coordinating and problem solving cross-functionally with Quality, Operations, Validation, EHS and Technical Operations stakeholders.
- Bachelor’s Degree in an engineering or science discipline.