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CSV Consultant

Karwell Technologies

  • Raritan, NJ
  • 30+ days ago

    Highlights

    Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports). Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures.

    Numbers & Facts

    LocationRaritan, NJ

    Description

    Job Description:
    • CSV Consultant role supporting system validation activities in a regulated environment, ensuring compliance with FDA guidelines, GxP standards, and risk-based validation approaches.
    • The role involves working within the System Development Lifecycle (SDLC) and contributing to validation documentation and testing processes.
    • Strong verbal and written communication skills.
    Requirements:
    • Experience in the pharmaceutical, biotechnology, or medical device industry.
    • 2+ years of experience with System Development Lifecycle (SDLC).
    • 3+ years of experience in Computer System Validation (CSV).
    • Experience in FDA and/or global regulated environments with a good understanding of GxP standards and risk-based validation.
    • Knowledge of FDA guidance and industry standards (e.g., GAMP).
    • Ability to work as a team player, lead a team or accomplish tasks without supervision. Ability to work with remote teams and support several changes/projects simultaneously.
    • Experience in writing and executing documentation for all aspects of validation deliverables (e.g., Requirements, Compliance/Validation Plans, Test Protocols, Test Summary Reports, Compliance/Validation Reports).
    • Experience in reviewing system test and user acceptance test (UAT) scripts, Traceability Matrix, and Design Specifications.
    • Experience in QA methodologies, including designing, reviewing, and approving Test Plans, system test scripts, UAT scripts, and test procedures.

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