Website Asset Recruitment

Asset Recruitment

SW2 01065

SENIOR CLEAN PROCESS UTILITIES EQUIPMENT LEAD

An exciting new long term contract opportunity has arisen for an  experienced Senior Process Utilities Equipment Lead who will take responsibility for design coordination, specification, FATs / SATs and qualification of Various Utility Equipment Packages supporting Drug Substance Bioprocessing Suites. Reporting to the Process Equipment Project Manager this is a key role in this major life science project.

DUTIES

  • Lead a Project Team in Specification, Testing, Commissioning and Qualification of various vendor and Stick Build Process Utility Packages such as Pure Steam Generators, WFI Stills/ Pre-treatment, WFI Storage & Distribution Systems, Process Gasses, CIP Skids & Distribution Systems and Process Waste systems.
  • Ensure Schedule adherence and Cost Control across Equipment Packages and provide regular updates to Project Manager.
  • Provide Client-Side Equipment Subject Matter Expertise Input during Detailed Design, P&ID Development, URS Development and Vendor Package Technical Reviews.
  • Lead Equipment Package FAT’s, SAT’s and CQV activities.
  • Provide SME support for on-site vendor and contractor activities concerning Equipment Installation, Commissioning and Qualification.

EXPERIENCE & QUALIFICATIONS

  • 10+ years Biopharma industry experience
  • 5+ years’ experience in large-scale Biopharma manufacturing environments.
  • Experience with PLC systems and integration with Control Systems such as Delta-V.
  • Biopharma Plant Start-Up experience desirable.
  • Previous experience with Parts Washers/Autoclaves an advantage.
  • Previous experience in Specification, Qualification, Operation of Equipment Packages listed above.
  • Expertise in Leading Full Life-Cycle Equipment Introduction Process from URS Development and Design Document Reviews, to FAT, SAT, Commissioning, IQ/OQ Planning/Execution supporting PPQ/Operational Readiness.
  • Experience in Leading Project Teams to ensure EHS, Validation, Technical Services, Quality and Manufacturing resources are identified and managed throughout te equipment package life cycles.
  • Experience coordinating and problem solving with Quality, Operations, Validation, EHS and Technical Operations stakeholders.
  • Bachelor’s Degree in a related science or engineering discipline.
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