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CSV Consultant

Katalyst Healthcares & Life Sciences

  • Philadelphia, PA
  • 8 days ago

    Highlights

    Summary: We're looking for an experienced Computer System Validation (CSV) Consultant to support a leading biotech client in validating bioinformatics software, scientific algorithms, and data analysis platforms within a GMP-regulated environment. Develop and execute Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Summary Reports.

    Numbers & Facts

    LocationPhiladelphia, PA

    Description

    Summary:
    We're looking for an experienced Computer System Validation (CSV) Consultant to support a leading biotech client in validating bioinformatics software, scientific algorithms, and data analysis platforms within a GMP-regulated environment.
    Roles & Responsibilities:
    • Validate bioinformatics software and data analysis systems.
    • Develop and execute Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Summary Reports.
    • Validate scientific algorithms and automated data processing workflows.
    • Support laboratory software, genomic analysis platforms, and cloud-based application implementations/upgrades.
    • Perform impact assessments and support change control activities.
    • Ensure compliance with GAMP 5, 21 CFR Part 11, and data integrity requirements.
    Preferred Experience:
    • Computer System Validation (CSV) in Pharmaceutical/Biotechnology environments.
    • Validation of laboratory or scientific software in GxP environments.
    • Bioinformatics, Genomics, NGS, or Computational Biology workflows.
    • Scientific algorithms and Python/R-based data analysis pipelines.
    • Strong knowledge of GAMP 5, 21 CFR Part 11, and data integrity principles.
    • Experience collaborating with Quality, IT, Bioinformatics, and Laboratory teams.

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