*Role:
Our client is looking for a Process Validation/Commissioning Engineer for a 6-9 month process. This client is in the execution stage right now, so this consultant will come in and do the execution work. Would be good if the consultant has writing protocol experience but most of this will be execution work. If the consultant has automation or delta V experience would be helpful. No coding involved, just to be able to talk to automation team during the project. This consultant will be assisting with FAT, IQ, and Commissioning. Will also be reviewing Turn Over Packages. For Equipment any experience with UF, Chromatography Skids or Bioreactor experience would be preferred. Atleast 5 years of Process Validation/Commissioning experience.
Skills/Knowledge:
Commissioning, PIDs, biotech, cGMP, ISA data sheets, valve sizing, pump sizing, CIP/SIP, URS, FS/FDS/FRS, BPE, communication, organization, problem solving, hands-on, self-motivated.
UF, Chromatography, and/or Bioreactor experience preferred.
Some automation experience with either DeltaV or PLC is preferred.
Job Description
• Author/review/update URS and FS documentation (some automation experience preferred).
• Highlight PID process flow path diagrams for Functional Specifications.
• Review and provide feedback on PIDs.
• Review and provide feedback on component lists and data sheets.
• Author/review FAT protocols.
• Author/review commissioning protocols (IQ/OQ) including CIP/SIP.
• Perform P&ID walkdowns to record As-Built conditions and provide feedback to Engineering.
• Assist with FAT, IQ and commissioining/start-up as necessary including protocol execution and troubleshooting.
• Review vendor Turn-Over-Packages for completeness and accurateness.
• Assist with punchlist closure.
*Most Important Skills Needed: Process Validation, Commissioning, Execution
Education Requirements: Engineering Degree preferred
NH: Process Validation Engineer (233291)
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