Job Description

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:

• 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).

Job Tags

Full time, Part time, Remote work,

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