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CSV Project Lead

2 months ago


Hampshire, United Kingdom Intellectt INC Full time

Job Title: CSV Project Lead
Location: New Hampshire MA
Duration: 12 months plus

Job Description:

  • 10 years of experience in Computer Systems Validation
  • Strong knowledge in validation lifecycle of Facilities Utilities Process Equipment Computerized Systems and Analytical Instruments
  • Familiarity with biologics (mammalian CGT) and chemical manufacturing technologies is desirable
  • Provide necessary training for project CSV engineers
  • Lead the project
  • Serve as the Lead Engineer / Liaison for the C&Q and CSV Teams
  • Support C&Q / CSV lifecycle and testing document reviews and approvals throughout the project
  • Provide technical SME input for document development and testing activities
  • Drive resolution of testing incidents engineering changes and automation changes
  • Support management of CSV project controls and progress reporting
  • Assist C&Q manager in developing/updating CSV timeline throughout the project
  • Strong knowledge of Software Development Lifecycle (SDLC) including 21CFR part 11/Annex 11 and Data Integrity
  • Provide high-level guidance/strategy for CSV activities
  • Review and approve CSV Documentation (URS FS DQ IV/IQ OV/OQ OPQ and Summary Reports) as required
  • Provide CSV oversight on engineering change controls and automation changes
  • Experience working independently as well as in a team-oriented collaborative environment
  • Experience with Kneat is essential
  • Strong verbal and written communication skills
  • Support projects during regular work hours with some overtime as needed

Education & Experience:

  • 10 years of experience in Computer Systems Validation

Required Skills:

  • CSV Project Lead
  • Computer Systems Validation
  • Kneat
  • Automation