Instrument Software Validation Analyst

Req ID:370118NTT 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.We are currently seeking a Instrument Software Validation Analyst to join our team in Cincinnati, Ohio (US-OH), United States (US).Job Title: Instrument Software Validation AnalystLocation - Work from client office - 2110 East Galbraith Road, Cincinnati, OH 45237OverviewWe are 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 ResponsibilitiesSoftware Validation & ComplianceValidate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelinesDevelop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)Ensure systems remain in a validated state throughout their lifecycleDocumentation & Regulatory SupportAuthor and maintain validation documentation including:Validation Plans and ReportsUser Requirement Specifications (URS)Functional/Design SpecificationsTraceability MatricesEnsure compliance with 21 CFR Part 11, GAMP 5, and data integrity standardsSystem Analysis & DesignGather and document system requirementsDevelop software specifications and validation test casesCreate infrastructure diagrams and data flow documentationDocument current-state software configurationsTesting & ExecutionPerform functional, integration, regression, and data integrity testingIdentify, document, and troubleshoot validation deviationsConduct root cause analysis and collaborate with cross-functional teams to resolve issuesRisk & Change ManagementConduct risk assessments (e.g., FMEA) to identify and mitigate system risksSupport and implement change control procedures for software updates and enhancementsTransition legacy SOPs to updated IT software management SOPsRequired QualificationsEducation: Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related fieldExperience: 2–5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices)Required Skills & CompetenciesRegulatory Knowledge5+ years of strong understanding of:FDA, EMA, and GMP regulations21 CFR Part 11GAMP 5 guidelinesData integrity principlesTechnical Expertise3 to 5 years of experience with:Laboratory systems such as LIMSChromatography Data Systems (e.g., Empower)Familiarity with validation lifecycle and documentation standardsCore CompetenciesStrong analytical and problem-solving skillsExcellent technical writing and documentation abilitiesAttention to detail with a quality-focused mindsetAbility to work cross-functionally with IT, QA, and business teamsPreferred QualificationsExperience in global regulatory environmentsExposure to instrument software in laboratory or manufacturing settingsKnowledge of SOP migration and system lifecycle managementAbout NTT DATANTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, .NTT DATA endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. 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. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.Posting Date:04/28/2026Department:Delivery - QAT Solutions - HP, Prov & LS - 1421910011