HELISHORES, INC
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
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.
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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
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.
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