CSV Specialist / CSV Consultant - MES Validation

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

Engagement Detail

Requirement

Pharmaceutical / Life Sciences

Manufacturing Execution System (MES)

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

Area

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.

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.

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