Req ID: 370118 NTT DATA's Client is currently seeking an Instrument Software Validation Analyst to join their team in Cincinnati, Ohio (US-OH), United States (US). Overview NTT DATA's Client is seeking an experienced Instrument Software Validation Analyst to ensure that 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) Required Skills & Competencies Regulatory Knowledge 5+ years of strong understanding of: FDA, EMA, and GMP regulations 21 CFR Part 11 GAMP 5 guidelines Data integrity principles Technical Expertise 3 to 5 years of experience with: Laboratory systems such as LIMS Chromatography Data Systems (e.g., Empower) Familiarity with validation lifecycle and documentation standards Core Competencies 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 Where required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting hourly range for this role is Hourly rate $45.00hr to $50.00/hr. Actual compensation will depend on several factors, including the candidate's relevant experience, technical skills, and other qualifications. This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and 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.