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CSV Analyst

Karwell Technologies

  • Cincinnati, OH
  • 30+ days ago

    Highlights

    This position serves as a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements. The role focuses on the integration layer, ensuring data moves accurately and completely from instruments through Instrument Manager into the LIS and related downstream workflows.

    Numbers & Facts

    LocationCincinnati, OH

    Description

    Job Summary:
    • We are seeking a CSV Analyst with Instrument Integration & Validation expertise to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments.
    • The role focuses on the integration layer, ensuring data moves accurately and completely from instruments through Instrument Manager into the LIS and related downstream workflows.
    • This position serves as a bridge between technical software validation, testing, and regulatory compliance, ensuring systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements.
    Roles & Responsibilities:
    • Validate software used in laboratory and manufacturing instruments in compliance with FDA, EMA, and GxP guidelines.
    • Develop and execute validation protocols including IQ, OQ, and PQ.
    • Ensure systems remain in a validated state throughout their lifecycle.
    • Author and maintain validation documentation such as Validation Plans, Reports, URS, Functional/Design Specifications, and Traceability Matrices.
    • Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards.
    • Gather and document system requirements.
    • Develop software specifications, validation test cases, and supporting documentation.
    • Create infrastructure diagrams, data flow diagrams, and document current system configurations.
    • Perform functional, integration, regression, and data integrity testing.
    • Identify, document, and troubleshoot validation deviations.
    • Conduct root cause analysis and collaborate with cross-functional teams for issue resolution.
    • Conduct risk assessments (FMEA) to identify and mitigate system risks.
    • Support change control processes for software updates and enhancements.
    • Assist in transitioning legacy SOPs to updated IT/software management SOPs.
    • Perform regulated laboratory validation activities.
    • Support requirements gathering and documentation.
    • Author and execute validation test cases.
    • Perform IQ/OQ/PQ, UAT, and end-to-end testing.
    • Conduct risk assessments and support change control activities.
    • Perform technical writing and objective evidence collection.
    • Verify data integrity across systems.
    • Support instrument integration workflows.
    • Work with Instrument Manager or similar middleware.
    • Validate instrument-to-middleware-to-LIS data flow.
    • Support LIS, downstream reporting, and QC-related workflows.
    • Ensure alignment with CAP, CLIA, 21 CFR Part 11, and GAMP risk-based validation expectations.
    Education & Experience:
    • Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
    • 2 5+ years of experience in Computer System Validation (CSV) or software validation within pharmaceutical, biotech, or medical device industries.
    • Strong understanding of regulatory requirements including FDA, EMA, GMP, 21 CFR Part 11, and GAMP 5.
    • Hands-on experience with laboratory systems such as LIMS and Chromatography Data Systems (e.g., Empower).
    • Experience with validation lifecycle processes, documentation standards, and data integrity principles.
    • Strong regulated laboratory validation experience in Instrument Integration & Validation.

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