Computer System Validation (CSV) Engineer
Carlton National Resources • Wakefield, MA, US
1 day ago
Job description
Computer System Validation (CSV) Engineer
Position Overview: The Computer System Validation (CSV) Engineer is responsible for the validation of computerized systems and infrastructure within regulated environments. This role involves developing and executing validation protocols to ensure compliance with 21 CFR Part-11, Annex-11, and other regulatory standards.
Key Responsibilities:
- Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
- Manage and update validation activities, ensuring alignment with day-to-day operations and project work.
- Review and provide feedback on System Delivery Life Cycle (SDLC) documents, ensuring adherence to Standard Operating Procedures (SOPs).
- Author and update SOPs, templates, and related documentation to support ongoing CSV compliance.
Required Qualifications:
- Bachelor's degree in Computer Science, Life Sciences, or related field.
- 5+ years of experience in computer system validation within life sciences.
- Knowledge of CSV regulatory standards (21 CFR Part-11, Annex-11, GAMP5).