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SENIOR PROCESS EQUIPMENT LEAD- UPSTREAM
An exciting new long term contract opportunity has arisen for an experienced Senior Process Equipment Lead – Upstream takes responsibility for design coordination, specification, FATs and SATs and qualification of vendor equipment packages in upstream mammalian cell-based bioprocessing suite. Reporting to the Process Equipment Project Manager this is a key role in this major Biopharmaceutical project.
EXPERIENCE & QUALIFICATIONS
- 10+ years’ experience working on large scale Biopharmaceutical Construction Projects
- 5+ experience in Upstream Large-Scale Biopharma Manufacturing environment.
- Experienced in Automation Systems (Delta-V ideal).
- Biopharma plant start-up experience desirable.
- Experienced in Specification, Qualification, Operation of Single-Use Bioreactors, Centrifuges, Wave Bag Technology.
- Experienced in leading Full Life-Cycle Equipment Introduction Process, URS Development, Design
- Document Reviews thru to FAT, SAT, commissioning, IQ/OQ planning/execution and supporting PPQ/operational readiness.
- Experience coordinating and problem solving cross-functionally with Quality, Operations, Validation, EHS and Technical Operations stakeholders.
- Experience Leading Project Teams to ensure EHS, Validation, Technical Services, Quality and Manufacturing resources identified and managed throughout Equipment Package Life Cycles.
- Bachelor’s Degree in Science or Engineering discipline.
- Lead project team in Specification, Testing, Commissioning and Qualification of Upstream Vendor Packaged Equipment Such as Single Use Bioreactors, Centrifuges, Rocker Bioreactors, TCU’s, Filtration Bio-Safety Cabinets, Skids and Cell Bank Storage.
- Provide Client-Side Upstream Equipment Subject Matter Expertise during Inoculation/Upstream Suite Detailed Design, URS development, P&ID Development and Vendor Package Tech Reviews.
- Provide SME support for on-site vendor and contractor activities related to Suite and Equipment Installation and CQV.
- Lead Equipment Package FAT’s, SAT’s and CQV activities.
- Ensure Schedule Adherence and Cost Control across Equipment Packages and provide regular updates to Project Manager.