Csv Consultant

We want to shape the future with vision and innovation. Be part of it and develop your full potential!

As part of the global NTT DATA Group, one of the most successful IT service providers in the world, we specialize in value-added SAP solutions as NTT DATA Business Solutions. With over 12,000 employees in more than 31 countries, we design, implement, and develop custom-fit SAP solutions for our global customers.

Would you like to take the next step in your career and be part of our highly qualified team?

Are you ready to break new ground?

Job Title: SAP CSV Consultant

Experience: 5+ Years

Job Location: Hyderabad/Pune/Chennai/Mumbai

Travel: Requires travel (international and domestic)

Are you ready to break new ground? Convince us with your potential.

Job Summary:

We are looking for a highly experienced Computer System Validation (CSV) Specialist to support our SAP implementation projects. The ideal candidate will ensure compliance with regulatory requirements, such as FDA 21 CFR Part 11, EU Annex 11, and other industry standards, by executing end-to-end validation activities. This role involves working closely with project teams to validate SAP systems, ensuring data integrity, quality assurance, and adherence to Good Automated Manufacturing Practices (GAMP).

Responsibilities:

• Validation Strategy & Planning
• Develop and implement Computer System Validation (CSV) strategies and plans for SAP projects.
• Author validation deliverables, including Validation Plans (VP), Risk Assessment (RA), and Traceability Matrix (TM).
• Define and execute a test strategy, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.
• Compliance & Regulatory Alignment
• Ensure compliance with global regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and industry-specific standards (e.g., GAMP 5).
• Collaborate with quality assurance (QA) teams to ensure audit readiness and support regulatory inspections.
• Provide guidance on data integrity, change control, and documentation practices.
• Validation Execution
• Coordinate and execute validation testing, including system setup, configuration, and upgrades in SAP environments (e.g., S/4HANA, ECC, Fiori).
• Perform gap analysis for existing SAP implementations and recommend remediation actions.
• Document test results, deviations, and resolutions in alignment with project timelines.

Collaboration & Stakeholder Management

• Work with SAP implementation teams, business process owners, IT teams, and quality assurance to align on project goals and validation deliverables.
• Provide training and awareness sessions to stakeholders on CSV and compliance requirements.
• Act as the point of contact for CSV-related queries and audits.

• Continuous Improvement
• Establish best practices for validation activities and maintain validation frameworks for SAP systems.
• Evaluate and recommend tools and methodologies for efficient validation processes.

Knowledge

• Bachelors degree in Computer Science, Life Sciences, Engineering, or related field.
• 5+ years of experience in CSV within SAP implementations or similar ERP systems.
• Deep understanding of SAP modules (S/4HANA, ECC, Fiori) and their validation requirements.
• Strong knowledge of regulatory frameworks: FDA 21 CFR Part 11, EU Annex 11, GxP, and GAMP 5.
• Experience in authoring and managing validation documentation.

Preferred Qualifications

• SAP-specific certification or CSV-related certifications.
• Familiarity with validation of cloud-based SAP environments.
• Experience with other validation systems and tools, such as HP ALM, JIRA, or test automation solutions.
• Knowledge of pharmaceutical, biotech, or medical device industry standards and processes.

That is what makes us special-

• Team-oriented corporate culture, collaboration as equals and steady knowledge transfer
• Active participation in shaping your future.
• Individually tailored mentoring program
• Sustainable career support with our career model and individual development programs
• International project opportunities and networks

Do you have questions?

• We are looking forward to receiving your complete application documents (cover letter, CV and references) stating the earliest date you could start.

Get empowered by NTT DATA Business Solutions!

• Are you the person we're looking for? If yes, we look forward to receiving your application for this vacancy. Write to Satyendra.TVNR@nttdata.com;

Let's meet.

Are you the person we're looking for? If yes, we look forward to receiving your application for this vacancy.