Instrument Software Validation Analyst

Company Overview NTT DATA strives to hire exceptional, innovative, and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward‑thinking organization, apply now. NTT DATA's Client is currently seeking an Instrument Software Validation Analyst to join their team in Cincinnati, Ohio, United States. Job Overview We are seeking an experienced Instrument Software Validation Analyst to ensure laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between technical software testing and regulatory compliance. Key Responsibilities Software Validation & Compliance 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 Documentation & Regulatory Support Author and maintain validation documentation including Validation Plans and Reports, User Requirement Specifications (URS), Functional/Design Specifications, 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 and validation test cases Create infrastructure diagrams and data flow documentation Document current‑state software 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 to resolve issues Risk & Change Management 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 Education: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field Experience: 2‑5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices) Regulatory Knowledge: 5+ years of strong understanding of FDA, EMA, GAMP 5, 21 CFR Part 11, and data integrity principles Technical Expertise: 3‑5 years of experience with Laboratory Information Management Systems (LIMS), chromatography data systems (e.g., Empower), and familiarity with validation lifecycle and documentation standards Core Competencies: strong analytical and problem‑solving skills; excellent technical writing and documentation abilities; attention to detail; 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 Compensation & Benefits Hourly rate $45.00hr to $50.00/hr (actual compensation will depend on experience and qualifications). The position is eligible for company benefits such as medical, dental, vision insurance, flexible spending or health savings account, life and AD&D insurance, short‑ and long‑term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits. Equal Employment Opportunity NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. #J-18808-Ljbffr NTT DATA North America