Katalyst CRO

Computer System Validation Consultant

Saint Joseph, MO, US

Contract
3 months ago
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Summary

Responsibilities

  • Support client site with computer-related systems validation activities.
  • Work in a GMP environment in lifecycle documentation development, protocol execution and leading project efforts for computerized systems including laboratory, computer, and LIMS systems, etc.
  • Supporting identifying Gaps in Lifecycle documentation and leading efforts to correct the Gaps.
  • Support the CSV team to ensure they are achieving all identified goals and objectives.

Requirements:

  • Minimum of Six (6) years performing lifecycle computer-related systems validation in the biological manufacturing (GMP) industries.
  • Computer Science bachelor's degree: preferred.
  • The equivalent combination of education/experience may be accepted in lieu of degree.
  • Experience with computerized systems (e.g., Laboratory, LIMS, etc.).
  • Experience with ERP systems (SAP, QMS (Veeva Vault), LIMS (MODO), PV Works).

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