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Senior Computer System Validation (CSV) Analyst

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NTT DATA

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Location:
India , Hyderabad

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

We 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. This 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. The 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.

Job Responsibility:

  • Lead the development, review, and approval of Validation Plans, URS, FS, DS, RTM, and Validation Summary Reports
  • Define and implement risk-based validation strategies aligned with GAMP 5
  • Establish and standardize validation documentation practices across projects and systems
  • Ensure all deliverables comply with GxP, FDA, and EU regulatory requirements
  • Oversee execution of IQ, OQ, PQ protocols, ensuring completeness, accuracy, and compliance
  • Provide technical leadership during validation activities and troubleshooting
  • Coordinate with IT, QA, Engineering, and business stakeholders to ensure timely delivery
  • Review and approve test scripts, execution results, and deviation reports
  • Act as a subject matter expert (SME) for FDA 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), GAMP 5 framework
  • Lead risk assessments (FMEA, risk ranking) to define validation scope and effort
  • Ensure inspection readiness and adherence to global regulatory expectations
  • Ensure systems remain in a validated state throughout their lifecycle
  • Lead change control processes, impact assessments, and revalidation strategies
  • Drive periodic reviews and validation lifecycle maintenance activities
  • Support and lead CAPA investigations related to validation or system compliance issues
  • Act as a primary point of contact during internal audits and regulatory inspections
  • Present validation strategies, documentation, and compliance evidence to auditors
  • Identify gaps and drive remediation activities to maintain audit readiness
  • Mentor and guide junior CSV analysts and validation engineers
  • Provide training on validation processes, regulatory expectations, and best practices
  • Influence cross-functional teams and stakeholders in global environments

Requirements:

  • Bachelor's degree in Computer Science, Life Sciences, Engineering, or related field
  • 12+ years of hands-on experience in Computer System Validation (CSV) in FDA-regulated industries (Pharmaceuticals, Biotechnology, or Medical Devices)
  • 5+ years of extensive expertise in GAMP 5 methodology
  • Software Development Life Cycle (SDLC)
  • Risk-based validation approaches
  • Data integrity principles (ALCOA+)
  • FDA 21 CFR Part 11 and EU Annex 11
  • Proven experience leading validation projects and working in global, cross-functional teams

Nice to have:

  • Strong experience with enterprise systems such as LIMS, ERP, MES, QMS
  • Experience with cloud-based and SaaS validation (CSV/CSA approach)
  • Knowledge of Computer Software Assurance (CSA) framework (FDA guidance)
  • Excellent documentation, communication, and stakeholder management skills
  • Demonstrated ability to lead complex validation programs and regulatory interactions

Additional Information:

Job Posted:
May 11, 2026

Employment Type:
Fulltime
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