Validation Engineer - Raritan - Global Pharmaceutical Company

    Global Pharmaceutical Company
    Global Pharmaceutical Company Raritan

    1 day ago

    Description

    Job Details:

    Global Pharmaceutical Company

    Role - Sr. CSV Engineer

    Location - Raritan, NJ - Hybrid (2-3 days onsite, the rest remote)

    Pay rate available for w2 and c2c

    experience working with divestitures, mergers, and acquisitions is a huge plus

    experience managing offshore and guiding junior validation engineers and teams in a plus

    experience with jira, qtest, service now/iris, saas/paas applications, and gxp/erp applications is a huge plus

    Job Details:


    • 7+ years' experience in Computer System Validation or Quality management or Business Analysis in GxP application area


    • Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.


    • Developing validation strategy for projects


    • Providing audit support and support Application Lifecycle Management


    • Managing/guiding/overseeing periodic checks


    • Ability to guide cross-functional teams and mentor junior staff


    • Broad experience in Computer System Validation (CSV) and testing


    • Acquainted with Good Clinical Practices (GCP) regulatory requirements and FDA 21 CFR Part 11


    • Clear written and verbal communication, especially for technical documentation


    • Acquainted with both the agile and waterfall software development methodology


    • Solid understanding of the fundamentals of iterative and incremental software development


    • Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems


    • Skilled in project planning, execution and minimal rework strategies


    • Capable of risk identification and mitigation, especially in regulated environments


    • Strong Analytical and Problem solving


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