Computer System Validation Engineer-New Jersey Job at HELISHORES, INC, Parlin, NJ

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  • HELISHORES, INC
  • Parlin, NJ

Job Description

Job Description Job Description Role: Computer System Validation Engineer Location: New Jersey Exp: 10+ years Required Skills & 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 Experience with cloud-based GxP systems. Familiarity with data integrity principles. Previous experience in audit preparation and support. 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. 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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