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CSV Analyst

Katalyst Healthcares & Life Sciences
  • Cincinnati, OH
  • Quick Apply
30+ days ago

Job 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.

Numbers & Facts

LocationCincinnati, OH

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