CSV Analyst with Instrument integration & Validation expertise

About the role

Make an impact with NTT DATA Join a company that is pushing the boundaries of what is possible. We are renowned for our technical excellence and leading innovations, and for making a difference to our clients and society. Our workplace embraces diversity and inclusion - it's a place where you can grow, belong and thrive. We are seeking for a 7+ years of strong regulated lab validation experience in Instrument integration & Validation Analyst to support validation and compliance of laboratory, manufacturing, and embedded software systems in regulated environments to the integration layer - confirming that data moves accurately and completely from the instrument, through Instrument Manager, into the LIS, and through any related downstream workflows. The role ensures systems operate reliably and remain in a validated state in accordance with EMA and GxP requirements. This position acts as a bridge between technical software validation, testing, and regulatory compliance. Roles & Responsibilities: Software Validation & Compliance 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 7+ 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 Fluent in English, French and/or Dutch Workplace type : About NTT DATA NTT 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 part of NTT Group, which invests over $3 billion each year in R&D. Equal Opportunity Employer NTT DATA is proud to be an Equal Opportunity Employer with a global culture that embraces diversity. We are committed to providing an environment free of unfair discrimination and harassment. We do not discriminate based on age, race, colour, gender, sexual orientation, religion, nationality, disability, pregnancy, marital status, veteran status, or any other protected category. Join our growing global team and accelerate your career with us. Apply today. Third parties fraudulently posing as NTT DATA recruiters NTT DATA recruiters will never ask job seekers or candidates for payment or banking information during the recruitment process, for any reason. Please remain vigilant of third parties who may attempt to impersonate NTT DATA recruiters-whether in writing or by phone-in order to deceptively obtain personal data or money from you. All email communications from an NTT DATA recruiter will come from an @nttdata.com email address. If you suspect any fraudulent activity, please contact us .

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