Website Asset Recruitment

Asset Recruitment

SW2 01064

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.

DUTIES

  • 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.
Upload your CV/resume or any other relevant file. Max. file size: 40 MB.


You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.