What are the responsibilities and job description for the Computer System Validation Consultant position at Katalyst CRO?
Roles & Responsibilities
- 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).
- 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.
