CSV Analyst
Saint-Paul-en-Born, Minnesota, United States
Job Description
Job Description:
- 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.
- 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.
- uthor 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.
- ssist in transitioning legacy SOPs to updated IT/software management SOPs.
- Perform regulated laboratory validation activities.
- Support requirements gathering and documentation.
- uthor 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.
- 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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