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CSV Lead

Job

Amzur Technologies, Inc.

Princeton, NJ (In Person)

Full-Time

Posted 3 days ago (Updated 20 hours ago) • Actively hiring

Expires 7/24/2026

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Job Description

This role will be supporting validation leads to help ensure the required deliverables and testing are complete according to the Client CSV SOP. Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel. Overall a solid CSV background and a strong work ethic in an aggressive project setting will be key to success in this role.
Required Skills:
Experience in the pharmaceutical, biotechnology, or medical device industry 10+ years of experience in Computer System Validation (CSV) Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation Knowledge of FDA guidance and industry standards (e.g., GAMP) Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports) Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures