Senior CSV Validation Analyst – Regulated Labs

Katalyst CRO; Cincinnati (OH); On-site; USD 95,000 - 140,000; Full time

Job summary

Katalyst CRO seeks an Instrument Integration & Validation Analyst with 10+ years of regulated lab validation experience to support validation and compliance of laboratory, manufacturing, and embedded software systems. The role bridges software validation, testing, and regulatory compliance in a GMP environment.

You will validate data movement from instruments through Instrument Manager to LIS and downstream workflows, ensuring systems stay validated per EMA and FDA/GxP standards while

Qualifications

• Bachelor's degree in CS, Engineering, Life Sciences, or related field.
• 2–5+ years of CSV or software validation in pharma/biotech/medical devices.
• Strong knowledge of FDA/EMA/GMP, 21 CFR Part 11, and GAMP 5.
• Experience with LIMS and Empower data systems.
• Experience with validation lifecycle documentation and data integrity.

Responsibilities

• Validate software used in laboratory and manufacturing instruments per FDA/EMA guidelines.
• Develop and execute validation protocols including IQ, OQ, and PQ.
• Maintain systems in a validated state throughout their lifecycle.
• Create and maintain validation documentation (Validation Plans, Reports, URS, Specs, Traceability Matrices).
• Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards.
• Gather and document system requirements; develop specs and validation test cases.
• Create infrastructure and data flow diagrams; document current configurations.
• Perform functional, integration, regression, and data integrity testing.
• Identify, document, and troubleshoot validation deviations; conduct root cause analysis.

Skills

Regulated validation

GxP compliance

Data integrity

Root cause analysis

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

Tools

LIMS

Empower

Job description

Katalyst CRO seeks an Instrument Integration & Validation Analyst with 10+ years of regulated lab validation experience to support validation and compliance of laboratory, manufacturing, and embedded software systems. The role bridges software validation, testing, and regulatory compliance in a GMP environment.

You will validate data movement from instruments through Instrument Manager to LIS and downstream workflows, ensuring systems stay validated per EMA and FDA/GxP standards while