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Katalyst Healthcares and Life Sciences

Computer System Validation Analyst - R Studio & Clinical Systems Job at Katalyst

Katalyst Healthcares and Life Sciences, Jersey City, NJ, United States, 07390

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Responsibilities:
  • Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC.
  • Develop and execute validation documentation including:
  • Validation Plans (VP.).
  • User Requirements Specifications (URS.).
  • Risk Assessments (RA.).
  • Functional and Design Specifications.
  • Traceability Matrix (RTM.).
  • Test Protocols (IQ/OQ/PQ or CSA-based scripts.).
  • Validation Summary Reports (VSR.).
  • Collaborate with cross-functional stakeholders including Clinical Data Management, Biostatistics, IT, and QA teams to gather requirements and ensure system compliance.
  • Coordinate and document test evidence in systems such as Val Genesis, Kneat, or other e-validation platforms.
  • Perform gap assessments, periodic reviews, and change control assessments for validated systems.
  • Ensure compliance with 21 CFR Part 11, Annex 11, ICH E6(R2), GAMP 5, and FDA CSA Guidance.
  • Support audit readiness by maintaining validation documentation and providing responses to internal/external auditors.
  • We are seeking a Computer System Validation (CSV) Engineer with strong experience validating statistical programming environments (R Studio), source code management systems (GitLab), and Clinical Data Management Systems such as Metadata Rave EDC.
  • The ideal candidate will be responsible for ensuring GxP compliance, data integrity, and adherence to Computer Software Assurance (CSA) principles throughout the validation lifecycle.
Requirements:
  • Bachelor's degree in computer science, Life Sciences, or related field.
  • 5+ years of experience in Computer System Validation in a regulated GxP environment.
  • Hands-on validation experience with, GitLab, and Medidata Rave EDC.
  • Strong understanding of FDA regulations (21 CFR Part 11), data integrity, and CSA methodology.
  • Experience with electronic validation lifecycle systems (Val Genesis, Kneat, etc.).
  • Strong documentation, analytical, and communication skills.
  • Knowledge of SDLC methodologies including Agile/DevOps validation frameworks.
  • Familiarity with clinical trials data and statistical programming environments.
  • CSA training or certification is a plus.