Instrumentation Software Validation Analyst

Katalyst CRO; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Cincinnati is looking for an experienced Instrument Software Validation Analyst. This role supports validation and compliance of laboratory and manufacturing software systems, ensuring they meet FDA, EMA, and GxP requirements. The ideal candidate will have over 25 years of experience in software validation within regulated industries, a strong understanding of regulatory requirements, and hands-on experience with LIMS and other laboratory systems. The position focuses on developing validation protocols and maintaining compliance documentation.

Qualifications

• 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.

Responsibilities

• Validate software for laboratory and manufacturing compliance.
• Develop and execute validation protocols including IQ, OQ, and PQ.
• Maintain validation documentation.
• Conduct risk assessments (FMEA) to identify system risks.

Skills

Computer System Validation (CSV)

Software validation in regulated environments

Regulatory compliance knowledge

Risk management

Education

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

Tools

LIMS

Chromatography Data Systems (e.g., Empower)

Job description

Overview

Job Summary We are seeking an experienced Instrument Software Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments. The role ensures systems operate reliably and remain in a validated state in accordance with FDA, EMA, and GxP requirements. This position acts as a bridge between technical software validation, testing, and regulatory compliance.

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

Documentation & Regulatory Support

• 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

System Analysis & Design

• 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

Testing & Execution

• 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

Risk & Change Management

• 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

Education & Experience

• 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