Carlton National Resources
Computer System Validation (CSV) Engineer
Carlton National Resources - Wakefield
Work at Carlton National Resources
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Overview
Job Title: Computer System Validation (CSV) Engineer
Job ID: 550
City: Wakefield
State: Massachusetts
Job Type: Full Time On-Site/Part Time On-Site/Full Time Remote/Part Time Remote/Full Time Hybrid
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:
Job ID: 550
City: Wakefield
State: Massachusetts
Job Type: Full Time On-Site/Part Time On-Site/Full Time Remote/Part Time Remote/Full Time Hybrid
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.
- 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).