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Raritan

    Computer System Validation Engineer - Raritan, United States - HCLTech

    HCLTech
    HCLTech Raritan, United States

    3 weeks ago

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    Description


    HCLTech is a global technology company, home to 211,000+ people across 52 countries, delivering industry-leading capabilities centered around digital, engineering and cloud, powered by a broad portfolio of technology services and products.

    We work with clients across all major verticals including Financial Services, Manufacturing, Technology and Services, Telecom and Media, Retail and CPG, Life Sciences and Healthcare and Public Services.

    Consolidated revenues as of 12 months ending June 20, 2022 totaled $11.8 billion. To learn how we can supercharge progress for you, visit

    HCLTech is looking to hire a Computer System Validation Engineer for our ongoing project engagements.

    This position requires the selected candidate to work from Raritan, NJ with no provision for Hybrid working options.


    Key Responsibilities:
    Compliance Analysis, Compliance Plan document, User Requirements document, Functional Requirements document, Risk Assessment document.
    System Test Protocol/ Scripts, User Acceptance Test Protocols/ Scripts, System Test Reports, User Acceptance Test Reports, Compliance Report.
    Exposure to ISO13485, 14971.
    Experience in computer systems validation.
    GXP regulatory knowledge and good documentation methods and CSA approaches and risk-based validation required.
    Prior experience in

    SAP ECC/S4 HANA system validation , Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required.

    Test automation tools and methods, authoring and/or reviewing validation deliverables such as Compliance Plan, Summary Report, Test Protocols, Test Scripts, Requirements and Trace Matrix is required.

    Experience working in Agile methodology and tools is required.

    #J-18808-Ljbffr
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