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NTT DATA Logo NTT DATA · IT - Software Development

CSV Specialist / CSV Consultant - MES Validation

India, Hyderabad · Job Posted June 02, 2026
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Job Description

We are looking for experienced CSV resources to support a Manufacturing Execution System project in a pharmaceutical manufacturing environment. The resources will support validation planning, documentation, testing, deviation management, traceability, and validation closure for MES implementation or enhancement activities.

Job Responsibility

  • Support validation planning, impact assessment, risk assessment, and validation strategy for the MES scope
  • Prepare and review validation documents such as Validation Plan, URS, FRS, DS, RTM, IQ, OQ, PQ, and Validation Summary Report
  • Prepare, review, and execute validation test scripts with objective evidence as per approved procedures
  • Log, track, investigate, and support closure of deviations, defects, and validation observations
  • Validate MES workflows, master data, recipes, electronic batch records, equipment integration, interfaces, and user roles
  • Ensure alignment with GxP, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, and internal quality standards
  • Maintain end-to-end traceability from requirements to testing and final validation closure
  • Work closely with MES functional team, technical team, QA, manufacturing SMEs, automation, and business users
  • Ensure validation deliverables are complete, controlled, and inspection-ready

Requirements

  • 5+ years of experience in Computer System Validation (CSV)
  • 3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
  • 3+ years of hands-on experience with MES validation and GxP validation lifecycle
  • Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
  • Experience in validation document preparation, review, execution, and approval workflows
  • Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
  • Strong documentation discipline and attention to detail

Nice to have

  • Werum PAS-X
  • Rockwell PharmaSuite
  • Siemens Opcenter Execution Pharma
  • Emerson Syncade
  • MasterControl Manufacturing Excellence
  • Any other pharma MES platform
  • Batch manufacturing process and electronic batch records (eBR)
  • Weighing and dispensing, equipment workflows, and material movement
  • Recipe management, line clearance, manufacturing execution, and review by exception
  • QA review, batch release process, audit trail review, and data integrity controls
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