Lead Computer System Validation (CSV) Engineer - Hybrid

NTT DATA Services•West Mifflin, PA

3d•$80,480 - $114,000•Hybrid

About The Position

We are seeking an experienced Lead Computer System Validation (CSV) Engineer to lead end-to-end validation activities for GxP-regulated enterprise applications, SaaS platforms, and computerized systems within a highly regulated Life Sciences environment. This is a hands-on leadership role for a CSV professional who can develop risk-based validation strategies, lead testing and documentation, manage validation issues and deviations, and partner with Quality, IT, Engineering, Operations, Business, vendors, and system owners through implementation and go-live. The ideal candidate brings strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, cGMP, GxP, and ALCOA+ data-integrity principles, along with experience validating SaaS and enterprise applications.

Requirements

6+ years of Computer System Validation (CSV) experience in pharmaceutical, biotechnology, medical device, healthcare, or another regulated Life Sciences environment.
Strong hands-on experience applying GAMP 5 risk-based validation methodology.
Strong working knowledge of: FDA 21 CFR Part 11, EU Annex 11, GxP / cGMP, ALCOA+ and data integrity, Computerized System Lifecycle Management
Proven experience developing and executing validation documentation, including URS, FRS, risk assessments, test plans/scripts, RTMs, qualification documentation, DMQs, SOPs, and Validation Summary Reports.
Strong experience with risk-based testing, requirements traceability, validation execution, and validation documentation.
Experience managing deviations, defects, root-cause analysis, CAPA, and corrective actions.
Experience validating SaaS/cloud-based applications in regulated environments.
Experience with data migration validation, reconciliation, sampling, and data-integrity verification.
Experience supporting application implementations, configuration changes, upgrades, patches, and regression testing.
Experience working effectively with Quality, IT, Engineering, Operations, Business, vendors, and system owners.
Strong communication, documentation, analytical, problem-solving, and stakeholder-management skills.
Ability to independently lead multiple validation workstreams and manage competing priorities.
Ability and willingness to work hybrid/partially on-site in Pittsburgh, PA.

Nice To Haves

Experience with one or more of the following is highly desirable: Veeva Vault / Veeva CDMS / Veeva CDB, EDC / eCOA platforms, Ultimo CMMS, IBM Maximo, Electronic Batch Records (EBR), OSCAR EBR, Oracle ERP, JAMA Connect, HP ALM / ALM Compliance, Jira, ServiceNow, Enterprise Quality Management Systems (QMS)
Experience validating complex migrations and integrations, including: Data migration planning and qualification, Source-to-target verification, Data reconciliation, Master-data validation, Statistical sampling and verification, Interface and integration testing, Data-integrity verification, Migration defect and deviation management, Post-migration validation and system stabilization
Experience applying emerging technologies to CSV and validation activities is a plus, including: AI-assisted test-script generation, AI-assisted risk assessment, Prompt engineering for CSV applications, AI model validation, Validation process automation, Automated requirements and traceability analysis
Candidates should understand the importance of human oversight, accuracy, traceability, documentation, and GxP compliance when applying AI to validation activities.

Responsibilities

Lead the full CSV lifecycle from planning and risk assessment through testing, implementation, go-live, and ongoing validated-state maintenance.
Develop risk-based validation strategies aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, cGMP, GxP, and ALCOA+.
Define validation scope, system criticality, testing requirements, and acceptance criteria.
Lead functional and system risk assessments and establish appropriate risk-based testing approaches.
Develop, review, and execute validation deliverables, including: Validation Plans / VMPs, URS / FRS, Risk Assessments, Test Plans and Test Scripts, I/O/PQ or equivalent qualification documentation, Data Migration Qualification (DMQ), Requirements Traceability Matrices (RTM), Validation Summary Reports (VSR), SOPs and Work Instructions
Lead validation execution across development, test/stage, and production environments.
Ensure complete traceability between requirements, risks, test cases, defects, deviations, and validation evidence.
Manage dry runs, formal testing, regression testing, defect resolution, deviations, and validation issue remediation.
Lead validation of SaaS, CMMS, EBR, clinical, ERP, and other regulated enterprise applications.
Support validation of platforms such as Veeva, Oracle ERP, IBM Maximo, Ultimo, EBR, EDC/eCOA, and related systems.
Lead or support data migration validation, including data mapping, reconciliation, sampling, source-to-target verification, and data-integrity assessments.
Perform audit-trail reviews and Data Integrity Assessments in accordance with ALCOA+ principles.
Validate electronic records, electronic signatures, security controls, user access, audit trails, workflows, integrations, and interfaces as applicable.
Lead root-cause analysis for validation failures, defects, and deviations and coordinate corrective actions.
Support change controls, patches, upgrades, configuration changes, and regression-testing assessments.
Partner with application owners, technical teams, Quality, vendors, and implementation partners throughout system implementation and stabilization.
Support vendor and SaaS assessments to ensure applicable quality and regulatory expectations are met.
Maintain audit-ready validation documentation using tools such as Jira, JAMA Connect, HP ALM/ALM Compliance, QMS, and ServiceNow.
Support regulatory inspections, internal audits, customer audits, and quality reviews.
Provide CSV guidance and training to project teams, system owners, business users, and junior validation professionals.
Lead validation readiness and provide risk-based recommendations for system release and go-live.