CSV Specialist

Technical & Engineering Consulting • Yauco, PR

2d

About The Position

The CSV Specialist will support compliance activities by preparing and reviewing validation documentation for identified systems in collaboration with user groups, QA, and IT. This role involves developing and maintaining various critical documents and ensuring effective computer change control procedures are followed. The specialist will also manage deviation reports when unexpected events occur during test script execution.

Requirements

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related scientific discipline.
• Proven experience in Computer Systems Validation (CSV) and System Development Life Cycle (SDLC) methodologies.
• Experience working in a pharmaceutical or other FDA-regulated environment.

Nice To Haves

• Strong attention to detail and ability to produce high-quality documentation.
• Excellent communication and collaboration skills with cross-functional teams.
• Knowledge of 21 CFR Part 11, GAMP 5, and other relevant industry standards.

Responsibilities

• Prepare and review validation documentation for identified systems in collaboration with user groups, QA, and IT.
• Develop and maintain documentation such as: Validation Plans, User Requirements, Functional Requirements, Design Specifications, Risk Assessments, OQ/PQ Protocols, User Acceptance Testing (UAT), Traceability Matrices, Validation Summary Reports.
• Ensure effective computer change control procedures are in place and followed.
• Manage deviation reports when unexpected events occur during the execution of test scripts.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level