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    • Computer Systems Validation Engineer - Navi Mumbai - Celito Tech, Inc.

    Celito Tech, Inc.
    Celito Tech, Inc. Navi Mumbai

    4 weeks ago

    Default job background
    Description

    Job Title: Computer System Validation Engineer (Offshore - Midlevel)

    The Computer System Validation Engineer is a key member of our team, responsible for ensuring that our clients' computer systems are validated and compliant with industry standards and regulatory guidance.

    Responsibilities:

    • Collaborate with project's CSV lead to execute GxP Computer System Validation activities
    • Work with internal and external stakeholders to manage resources and represent Celito Tech
    • Author and review validation deliverables, including change controls, system risk assessments, and test protocols
    • Maintain the validated state of client-supported GxP systems through periodic review and release management

    Qualifications:

    • Bachelor's degree in life sciences or engineering, with 3+ years of related experience
    • 3+ years of direct validation responsibilities in Computer Systems Validation
    • Strong knowledge of FDA Regulations, 21 CFR Part 11, Computer System Validation, and GAMP 5
    • Experience with validation of cloud-based Computer solutions and infrastructure qualification

    About Celito Tech:

    Celito Tech architects the buildout of simplified, integrated, and compliant technology stacks. Our expertise helps customers save time and money as they move from strategic Clinical & Quality management to widespread commercialization.

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