Computer System Validation Engineer Job at cGxPServe, New Jersey

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  • cGxPServe
  • New Jersey

Job Description

Roles & Responsibilities:
  • Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
  • 3 7 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.
  • Experience with cloud-based GxP systems.
  • Familiarity with data integrity principles.
  • Previous experience in audit preparation and support.

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