Senior Computer System Validation (CSV) Analyst

Req ID: 370274\n\nNTT 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.\n\nWe are currently seeking a Senior Computer System Validation (CSV) Analyst to join our team in Hyderabad, Telangana (IN-TG), India (IN).\n\n## Job Title: Senior Computer System Validation (CSV) Analyst\n\nExperience Required: 12+ Years \nIndustry: Pharmaceutical / Biotechnology / Medical Devices (FDA-Regulated)\n\n* * *\n\n## Job Summary\n\nWe are seeking a highly experienced and detail-oriented Senior Computer System Validation (CSV) Analyst to lead validation efforts for GxP-regulated computerized systems across IT, laboratory, and manufacturing environments.\n\nThis role is responsible for ensuring systems operate accurately, reliably, and in full compliance with global regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.\n\nThe ideal candidate will bring deep expertise in risk-based validation, lifecycle management, audit readiness, and regulatory compliance, while also providing strategic guidance and mentorship to cross-functional teams.\n\n* * *\n\n## Key Responsibilities\n\n### Validation Strategy \u0026 Documentation Leadership\n\n * Lead the development, review, and approval of Validation Plans, URS, FS, DS, RTM, and Validation Summary Reports.\n * Define and implement risk-based validation strategies aligned with GAMP 5.\n * Establish and standardize validation documentation practices across projects and systems.\n * Ensure all deliverables comply with GxP, FDA, and EU regulatory requirements.\n\n\n\n* * *\n\n### Validation Execution \u0026 Oversight\n\n * Oversee execution of IQ, OQ, PQ protocols, ensuring completeness, accuracy, and compliance.\n * Provide technical leadership during validation activities and troubleshooting.\n * Coordinate with IT, QA, Engineering, and business stakeholders to ensure timely delivery.\n * Review and approve test scripts, execution results, and deviation reports.\n\n\n\n* * *\n\n### Compliance, Risk \u0026 Data Integrity\n\n * Act as a subject matter expert (SME) for:\n * FDA 21 CFR Part 11\n * EU Annex 11\n * Data Integrity (ALCOA+)\n * GAMP 5 framework\n * Lead risk assessments (FMEA, risk ranking) to define validation scope and effort.\n * Ensure inspection readiness and adherence to global regulatory expectations.\n\n\n\n* * *\n\n### Lifecycle Management \u0026 Governance\n\n * Ensure systems remain in a validated state throughout their lifecycle.\n * Lead change control processes, impact assessments, and revalidation strategies.\n * Drive periodic reviews and validation lifecycle maintenance activities.\n * Support and lead CAPA investigations related to validation or system compliance issues.\n\n\n\n* * *\n\n### Audit \u0026 Inspection Leadership\n\n * Act as a primary point of contact during internal audits and regulatory inspections.\n * Present validation strategies, documentation, and compliance evidence to auditors.\n * Identify gaps and drive remediation activities to maintain audit readiness.\n\n\n\n* * *\n\n### Leadership \u0026 Mentorship\n\n * Mentor and guide junior CSV analysts and validation engineers.\n * Provide training on validation processes, regulatory expectations, and best practices.\n * Influence cross-functional teams and stakeholders in global environments.\n\n\n\n* * *\n\n## Required Qualifications\n\n * Bachelor\u2019s degree in Computer Science, Life Sciences, Engineering, or related field.\n * 12+ years of hands-on experience in Computer System Validation (CSV) in FDA-regulated industries (Pharmaceuticals, Biotechnology, or Medical Devices).\n * 5+ years of extensive expertise in:\n * GAMP 5 methodology\n * Software Development Life Cycle (SDLC)\n * Risk-based validation approaches\n * Data integrity principles (ALCOA+)\n * FDA 21 CFR Part 11 and EU Annex 11\n * Proven experience leading validation projects and working in global, cross-functional teams.\n\n\n\n* * *\n\n## Preferred Skills\n\n * Strong experience with enterprise systems such as:\n * LIMS, ERP, MES, QMS\n * Experience with cloud-based and SaaS validation (CSV/CSA approach).\n * Knowledge of Computer Software Assurance (CSA) framework (FDA guidance).\n * Excellent documentation, communication, and stakeholder management skills.\n * Demonstrated ability to lead complex validation programs and regulatory interactions.\n\n\n\nCSV) Analyst\n\nAbout NTT DATA\n\nNTT 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\u0027s 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\u0026D.\n\nWhenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client\u2019s 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, https://us.nttdata.com/en/contact-us.\n\nNTT DATA endeavors to make https://us.nttdata.com 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 https://us.nttdata.com/en/contact-us. 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\u0027d like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.\n