• Job Description

  Req#: 26-00722
  Company Overview:
  Req ID: 360803
  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.
  We are currently seeking a CSV Analyst to join our team in San Juan, Puerto Rico (PR-PR), Puerto Rico (PR).
  
  Job Description:
  Job Title: Computer System Validation (CSV) Analyst
  Location: San Juan, Puerto Rico
  Experience Required: 3-8 Years
  Industry: Pharmaceutical / Biotechnology / Medical Devices (FDA-Regulated)
  Job Summary
  We are seeking a detail-oriented and experienced Computer System Validation (CSV) Analyst to ensure that GxP-regulated computerized systems (IT, laboratory, and manufacturing systems) operate accurately, reliably, and in compliance with regulatory requirements including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
  The candidate will be responsible for maintaining systems in a validated state through risk-based validation approaches, lifecycle documentation, and audit readiness activities.
  Spanish language proficiency is mandatory for this role.
  Key Responsibilities
  Validation Documentation & Protocol Development
  Author, review, and approve Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), and Validation Summary Reports.
  Develop and execute validation protocols including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
  Ensure all documentation complies with GxP and regulatory requirements.
  Testing & Execution
  Perform and document IQ/OQ/PQ activities.
  Coordinate with cross-functional teams to ensure timely execution of validation deliverables.
  Document and manage deviations observed during testing.
  Compliance & Risk Management
  Ensure adherence to FDA 21 CFR Part 11, EU Annex 11, data integrity principles, and GAMP 5 methodology.
  Conduct risk assessments to determine the appropriate level of validation.
  Support periodic reviews and validation lifecycle maintenance.
  Lifecycle & Change Management
  Manage change control processes for validated systems.
  Support CAPA (Corrective and Preventive Action) activities.
  Ensure systems remain in a validated state throughout their lifecycle.
  Audit & Inspection Support
  Participate in internal and external audits and regulatory inspections.
  Provide validation documentation and compliance evidence during audits.
  Required Qualifications
  Bachelor's degree in Computer Science, Life Sciences, Engineering, or a related field.
  3-8 years of hands-on experience in Computer System Validation (CSV) within FDA-regulated industries (Pharmaceuticals, Biotechnology, or Medical Devices).
  3-8 years of strong understanding of:
  GAMP 5 methodology
  Software Development Life Cycle (SDLC)
  Data integrity principles
  FDA 21 CFR Part 11 and EU Annex 11
  Spanish language proficiency (reading, writing, and speaking) is mandatory.
  Preferred Skills
  3 years of experience with laboratory systems (LIMS), ERP, MES, or Quality Management Systems.
  Strong documentation and communication skills.
  Ability to work in cross-functional, global teams.
  Knowledge of risk-based validation approaches.
  
  About NTT DATA:
  
  NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com
  
  NTT 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'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.

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