Instrument Software Validation Analyst

JOB SUMMARY

We are seeking an experienced Instrument Software Validation Analyst to ensure the reliable and compliant operation of laboratory, manufacturing, and embedded software systems in accordance with regulatory requirements such as GxP/FDA/EMA. This role is crucial for maintaining validated systems through structured validation processes like Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), acting as a key link between technical software testing and regulatory compliance. The position requires onsite work at the client office located at 2110 East Galbraith Road, Cincinnati, OH 45237. Key Responsibilities

• Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines.
• Develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Ensure systems remain in a validated state throughout their lifecycle.
• Author and maintain validation documentation including Validation Plans and Reports, User Requirement Specifications (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 and validation test cases.
• Create infrastructure diagrams and data flow documentation.
• Document current-state software 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 to resolve issues.
• Conduct risk assessments (e.g., FMEA) to identify and mitigate system risks.
• Support and implement change control procedures for software updates and enhancements.
• Transition legacy SOPs to updated IT software management SOPs. Required Qualifications
• Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.
• 2-5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices).
• 5+ years of strong understanding of FDA, EMA, and GMP regulations.
• 5+ years of strong understanding of 21 CFR Part 11.
• 5+ years of strong understanding of GAMP 5 guidelines.
• 5+ years of strong understanding of data integrity principles.
• 3 to 5 years of experience with laboratory systems such as LIMS.
• 3 to 5 years of experience with Chromatography Data Systems (e.g., Empower).
• Familiarity with validation lifecycle and documentation standards.
• Strong analytical and problem-solving skills.
• Excellent technical writing and documentation abilities.
• Attention to detail with a quality-focused mindset.
• Ability to work cross-functionally with IT, QA, and business teams. Preferred Qualifications
• Experience in global regulatory environments.
• Exposure to instrument software in laboratory or manufacturing settings.
• Knowledge of SOP migration and system lifecycle management.