Hybrid Lead CSV Engineer — GxP SaaS Validation

NTT DATA, Inc.; Pittsburgh (Allegheny County); Hybrid; USD 80,000 - 114,000; Full time

Benefits offered by this job

Medical, dental & vision insurance (em

Employer contributions to benefits

Life and AD&D insurance

Short- and long-term disability

Paid time off

401(k) with company match

Job summary

NTT DATA, Inc. in Pittsburgh, PA, is seeking a Lead CSV Engineer for a hybrid role overseeing end-to-end validation of GxP systems, SaaS platforms, and enterprise applications in a highly regulated Life Sciences environment.

The role requires developing risk-based validation strategies, managing testing and documentation, and ensuring traceability across requirements, risks, tests, defects, and validation evidence, while collaborating with Quality, IT, Engineering, Operations, vendors, and

Qualifications

• 6+ years of CSV experience in regulated Life Sciences environments.
• Hands-on with GAMP 5 risk-based validation methodology.
• Strong knowledge of FDA 21 CFR Part 11 and EU Annex 11.
• Experience with GxP, cGMP, ALCOA+ data integrity.
• Proven ability to develop and execute validation documents (URS/FRS, RTMs, VSR).
• Experience validating SaaS/cloud-based applications.

Responsibilities

• Lead full CSV lifecycle from planning to go-live and maintenance.
• Develop risk-based validation strategies aligned with regulatory standards.
• Define scope, criticality, testing requirements, and acceptance criteria.
• Execute risk assessments and establish risk-based testing approaches.
• Create and review validation deliverables (URS/FRS, RTMs, DMQ, VSR, SOPs).
• Coordinate cross-functional validation activities with Quality, IT, Engineering, and vendors.

Skills

CSV experience

GAMP 5

FDA 21 CFR Part 11

EU Annex 11

GxP / cGMP

ALCOA+ / data integrity

SaaS validation

Data migration validation

Tools

Jira

JAMA Connect

HP ALM/ALM Compliance

QMS

ServiceNow

Job description

NTT DATA, Inc. in Pittsburgh, PA, is seeking a Lead CSV Engineer for a hybrid role overseeing end-to-end validation of GxP systems, SaaS platforms, and enterprise applications in a highly regulated Life Sciences environment.

The role requires developing risk-based validation strategies, managing testing and documentation, and ensuring traceability across requirements, risks, tests, defects, and validation evidence, while collaborating with Quality, IT, Engineering, Operations, vendors, and