Computer System Validation (CSV) Engineer

Carlton National Resources • Wakefield, MA

176d

About The Position

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.

Requirements

• 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).

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.

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 51-100 employees