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Validation Quality Control Engineer

2 months ago


Jersey City, New Jersey, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Develop and implement testing documentation for Good Manufacturing Practice (GMP) computerized systems while addressing any issues that arise during testing.
  • Possess a solid understanding of relevant regulations and methodologies.
  • Collaborate with the validation team on automated machinery and control systems.
  • Draft and update validation documents including User Requirement Specifications (URS), Design Requirements (DR), Computer System Validation (CSV) protocols, reports, and exception reports.
  • Evaluate vendor documentation, requirement specifications, and system implementation strategies.
  • Review and endorse System Testing/User Acceptance Testing (ST/UAT) scripts, Risk Assessment Reports (RRA), and implementation approvals.
  • Conduct reviews of retirement plans.
Essential Requirements:
  • Documentation of requirements, validation/test plans, requirement traceability matrices, change requests, impact assessment documents, and test/validation summary reports.