Senior CSV Engineer/Analyst

2 months ago


Concord, United States LS Solutions Full time

Role: Senior CSV Engineer/Analyst

Location: Concord, NC, 28027 (Onsite)

Duration: Fulltime role

Job Description:

  • 10 plus years of experience
  • 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 technical evaluation with site Tech, and 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 a remediation plan for computerized systems.
  • Responsible for creating CAPAs/Deviations and Change Requests in ServiceNow and Trackwise
  • Experience using HP ALM for authoring and executing the Test scripts.
  • Experience in performing/supporting computer validations associated with SDLC deliverables.



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