CSV Analyst

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.
• Auxiliary 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.

Requirements

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
• 25+ 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.