CSV Engineer/Analyst

Senior CSV Engineer/Analyst

General lab instrument
validation requirements. worked in a lab or have done lab validation
before for at least a year or 2

CSV expert for that one.

Requirements

 Responsible for supporting the
validation activities for local and global systems.

• Experience in developing and
  maintaining validation documentation including validation plans, test
  protocols, test scripts, and summary reports to align with company SOP and
  regulatory standards.
  
• Coordinate with technical
  evaluation with site Tech@Lilly subject matter experts (SMEs) of new and
  existing systems from a DI and CSV perspective.
  
• Responsible for coordinating with
  cross -functional teams to ensure the alignment of the validation activities.
  
• Perform data integrity gap
  assessment and develop remediation plan for computerized systems.
  
• Responsible for creating
  CAPA’s/Deviations and Change Requests in ServiceNow and Trackwise
  
• Experience using HPALM for
  authoring and executing the Test scripts.
  
• Experience in
  performing/supporting computer validations associated with SDLC deliverables