Sr. Computer Systems Validation Analyst

3 days ago


Foster City, California, United States Katalyst Healthcares & Life Sciences Full time

Roles & Responsibilities:

  • Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk
  • Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems.
  • Author documents related to GxP Systems
  • Draft Requirements and computer systems validation documents using GAMP 5
  • Execute test protocols for the software validation.
  • Initiate and execute change management for existing qualified systems.
  • Develop change management record, create or revise documentation if required, and execute implementation tasks.
  • Use understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system
  • Maintaining the project plan/schedule to meet deliverable commitments.

Education & Experience:

  • User and Configuration Specifications
  • System Impact Assessments
  • Risk Assessments
  • Installation Qualification Protocols
  • Operation Qualification Protocols
  • Performance Qualification Protocols
  • Traceability Matrix
  • Summary Reports Standard Operating Procedures
  • Authoring Change Controls
  • Authoring and executing test protocols
  • Managing Issue Reporting, Deviations and related CAPAs


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