GxP Validation Tester

GxP Software Validation Engineer

• Perform

  GxP software validation

  activities in compliance with

  FDA 21 CFR Part 11

  and

  EU Annex 11

  .


• Develop and execute

  validation deliverables

  , including

  Validation Plans, Test Plans, Test Cases, and Validation Summary Reports

  .


• Conduct

  functional, regression, and risk-based testing

  to validate system integrity.


• Ensure traceability and audit readiness by managing

  validation evidence

  .


• Collaborate with

  cross-functional teams

  to maintain

  GxP compliance

  across the software development lifecycle.


• Support and perform

  automation testing activities

  (desirable).


• Provide recommendations for

  process improvement and quality assurance

  .

• Experience:

  
  
  
  

  • 5+ years

    of overall experience, with at least

    3 years in GxP validation

    .
  
  
  • Strong understanding of

    GxP principles, regulatory requirements, and validation lifecycle processes

    .
  
  
  • Experience creating and managing validation artifacts (

    URS, FRS, IQ, OQ, PQ, and traceability matrices

    ).
  
  

  • Domain knowledge

    in

    regulated industries

    such as

    pharma, biotech, or life sciences

    .
  
  
  • Hands-on experience with

    testing tools and techniques

    (automation testing is a plus).
  
  
  • Familiarity with tools like

    JIRA, HP ALM, or other test management tools

    .
  
  
  • Strong

    analytical and communication

    skills for stakeholder collaboration.
  
  
  
  

• Experience with

  automation testing frameworks and tools

  (e.g.,

  Selenium, TestNG

  ).