Validation Specialist + Lab Instrument Support (19-00878) – CA – Pasadena

  1. Good Experience in Life Sciences, Computer System Validation and Testing
  2. Good understanding of FDA regulations, 21 CFR Part 11, GxP requirements along with knowledge of GAMP, GDP
  3. Experience working with Content management tool for Approval workflow creation e.g. Documentum , any other similar tools
  4. CSV (Computer System Validation) SOPs, SDLC and testing processes
  5. Experience in Creating/Reviewing Validation documents across the Validation Life Cycle like Validation Plan, Protocols (IQ,OQ,PQ), Incident Report, RTM, Validation Summary Report
  1. Experience working with LAB instrument software’s (installing, troubleshooting instrument software related issues)
  2. Experience working with LAB instrument vendor to troubleshoot instrument hardware /software related issues
  3. Experience working in LAB environments and basic understanding of different instruments
  4. Hands on experience creating accounts in instrument software’s
  5. Experience maintaining lab instrument inventories (physical inventory, software licenses, patches, accessories etc.)
  6. Experience in calibrating instruments by following SOP
  7. Experience executing IQ,OQ,PQ for instruments and instrument software’s

Source: Job Diva – Job Listing

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