Computer System Validation (CSV) Engineer

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 :

• 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 :