Computer System Validation Engineer

Overview

Role : Computer System Validation Engineer

Location : New Jersey

Exp : 10+ years

Qualifications

• Bachelor s degree in computer science, Engineering, Life Sciences, or related field.
• Need 10+ years of experience.
• 37 years of experience in CSV within pharmaceutical, biotech, or medical device industries.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines.
• Experience with ERP, LIMS, MES, or other GxP systems.
• Extensive Experience in HPALM with Manual testing.
• Deep knowledge in Defect Management Life cycle.
• Proficient in writing validation protocols, reports, and SOPs.
• Strong communication, documentation, and organizational skills.

Preferred Qualifications

Company Description

We strive to be a trusted partner as an IT Solution provider. We are committed to achieve Customer's Business Objectives by Delivering Professional Services & adopting Innovative Technologies. Our talent pool is then assessed comprehensively to provide the right fit in implementation a long-term solution. Our goal is to provide you with the right resources, with the right IT competencies who fit in seamlessly in your culture.

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