Computer System Validation Analyst - R Studio & Clinical Systems ...
Katalyst Healthcares and Life Sciences - Jersey City, NJ, United States, 07390
Work at Katalyst Healthcares and Life Sciences
Overview
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Overview
- 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.
- 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.