Lead CSV Engineer for GxP & SaaS Validation

NTT DATA, Inc.

United States

Hybrid

USD 80,000 - 114,000

Full time

11 days ago

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Job summary

Lead CSV Engineer at engineeringjobs.net, Inc. in Pittsburgh, PA, offers a hands-on leadership role within a regulated Life Sciences environment.

You will own end-to-end CSV activities for GxP-compliant systems, SaaS and enterprise applications, including risk-based validation, testing, documentation, and regulatory alignment. Ideal candidate has 6+ years in CSV, deep knowledge of GAMP5, FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity, with strong collaboration across Quality, IT,

Qualifications

6+ years of CSV experience in regulated Life Sciences environments.
Strong hands-on GAMP5 risk-based validation experience.
Experience with validation documentation: URS/FRS, RTM, VSR, DMQ, SOPs.

Responsibilities

Lead full CSV lifecycle from planning to go-live and maintenance.
Develop risk-based validation strategies aligned with GAMP5 and regulatory standards.
Define scope, testing requirements, acceptance criteria and traceability.
Lead risk assessments and testing across SaaS and enterprise apps.
Prepare and review validation deliverables (plans, scripts, DMQ, VSR, RTM).
Mentor junior staff and coordinate with Quality, IT, and Vendors.