Req ID: 371688 

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 Specialist / CSV Consultant - MES Validation to join our team in Hyderabad, Telangana (IN-TG), India (IN).

Job Description: CSV Specialist / CSV Consultant - MES Validation

Resouce needs to work from Hyderabad client office 5 days a week

Role Summary

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.

Key Responsibilities

Required Experience and Skills

• 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.

Preferred MES Experience

• Werum PAS-X
• Rockwell PharmaSuite
• Siemens Opcenter Execution Pharma
• Emerson Syncade
• MasterControl Manufacturing Excellence
• Any other pharma MES platform

Pharma Domain Knowledge

• 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.

Key Deliverables

• Validation Plan and Validation Risk Assessment.
• Requirement Traceability Matrix.
• IQ, OQ, and PQ protocols.
• Executed test scripts with objective evidence.
• Deviation, defect, and issue logs with closure evidence.
• Validation Summary Report.
• Approved validation package supporting MES go-live readiness.

Soft Skills and Working Style

• Strong communication and stakeholder management skills.
• Ability to work independently with clear ownership of assigned validation deliverables.
• Practical understanding of project timelines, validation pressure, and quality gates.
• Comfortable working with business users, QA reviewers, IT teams, and system vendors.
• Accountable, detail-oriented, and focused on inspection-ready delivery.

About NTT DATA

NTT 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's 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&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s 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.

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