Computer System Validation Analyst at Katalyst CRO

Position Computer System Validation Analyst
Posted 23 Feb 2026
Expired 25 Mar 2026
Company Katalyst CRO
Location Foster City | US
Job Type Full Time

Job Description:

Latest job information from Katalyst CRO for the position of Computer System Validation Analyst. If the Computer System Validation Analyst vacancy in Foster City matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

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Responsibilities
  • Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition
  • 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.
  • User and Configuration Specifications
  • System Impact Assessments
  • 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
Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Information Technology

Industries

Pharmaceutical Manufacturing

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Job Info:

  • Company: Katalyst CRO
  • Position: Computer System Validation Analyst
  • Work Location: Foster City
  • Country: US

How to Submit an Application:

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