Sr. Validation Engineer

NTT DATA•Pittsburgh, PA

12h•Hybrid

About The Position

We are seeking an experienced professional to lead end-to-end validation activities for enterprise applications and SaaS platforms within highly regulated Life Sciences environments. The ideal candidate will have strong hands-on experience developing and executing risk-based validation strategies for GxP-regulated computerized systems and ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, cGMP, data-integrity, and ALCOA principles. The candidate will work closely with Quality, IT, Engineering, Operations, Business, Application Owners, Vendors, and Project Management teams to define validation strategies, perform risk assessments, develop validation documentation, manage testing and deviations, support data migration, and ensure systems maintain their validated state throughout the application lifecycle. The candidate should be capable of independently leading validation workstreams across multiple projects and global sites while providing technical and compliance guidance to cross-functional teams.

Requirements

6 years of Computer System Validation (CSV) experience within pharmaceutical, biotechnology, medical device, healthcare, or other regulated Life Sciences environments.
3 to 5 years of strong hands-on knowledge of GAMP 5 risk-based validation methodology.
3 to 5 years of strong knowledge of FDA 21 CFR Part 11, EU Annex 11, GxP / cGMP, ALCOA Data Integrity principles, and computerized-system lifecycle management.
3 to 5 years of strong experience developing and executing validation documentation including VMP, URS, FRS, RTM, IOPQ, DMQ, risk assessments, test plans, SOPs, and Validation Summary Reports.
Experience performing functional risk assessments and risk-based testing.
Strong experience developing, reviewing, and executing validation test scripts.
Experience managing deviations, defects, root-cause analysis, CAPA, and validation issue resolution.
Strong understanding of requirements traceability and maintaining audit-ready validation documentation.
Experience validating SaaS/cloud-based applications within regulated environments.
Experience with data migration validation, reconciliation, sampling strategies, and data-integrity verification.
Experience performing audit-trail reviews and Data Integrity Assessments.
Experience supporting application implementations, configuration changes, upgrades, patches, and regression testing.
Experience working with Quality, IT, Engineering, Operations, Business, Vendors, and System Owners.
Strong stakeholder-management and cross-functional leadership capabilities.
Ability to independently lead multiple validation workstreams and manage competing priorities.
Excellent analytical, problem-solving, documentation, and communication skills.

Nice To Haves

Experience with one or more of the following would be advantageous: Veeva Vault / Veeva CDMS / Veeva CDB, EDC and eCOA platforms, Ultimo CMMS, IBM Maximo CMMS, Electronic Batch Records (EBR), OSCAR EBR, Oracle ERP, JAMA Connect, Client ALM / ALM Compliance, Jira, ServiceNow, Enterprise Quality Management Systems (QMS).
Experience supporting validation of complex system migrations and integrations, including data migration planning and qualification, source-to-target data verification, data reconciliation, master-data validation, statistical sampling and verification, interface and integration testing, data-integrity verification, migration defect and deviation management, and post-migration validation and stabilization.
Experience applying emerging technologies to validation activities would be beneficial, including AI-assisted test-script generation, AI-assisted risk assessment, prompt engineering for CSV use cases, AI model validation, validation process automation, automated requirements and traceability analysis.

Responsibilities

Lead end-to-end Computer System Validation (CSV) activities for GxP-regulated enterprise applications and SaaS platforms.
Develop and execute validation strategies aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, cGMP, GxP, and applicable regulatory requirements.
Define validation scope and apply risk-based validation and testing methodologies based on system criticality, business processes, and regulatory impact.
Develop and maintain validation lifecycle documentation, including Validation Master Plans (VMP), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and more.
Lead validation activities across Development, Test/Stage, and Production environments.
Develop, review, and execute validation test scripts and ensure complete traceability between requirements, risks, test cases, deviations, and validation evidence.
Conduct functional risk assessments and establish appropriate testing levels based on system and process risk.
Manage validation testing activities, including dry runs, formal execution, defect resolution, deviation management, and regression testing.
Lead validation activities for SaaS platforms, CMMS, EBR, clinical systems, ERP applications, and other regulated enterprise systems.
Support validation of systems such as Veeva Vault/CDMS, Veeva CDB, EDC/eCOA, Ultimo CMMS, Maximo CMMS, OSCAR EBR, Oracle ERP, and related platforms.
Support and validate complex data migration activities, including data mapping, reconciliation, data-integrity verification, sampling strategies, and migration qualification.
Perform Data Integrity Assessments (DIA) and audit-trail reviews to ensure compliance with ALCOA and applicable regulatory requirements.
Validate system security controls, user-access controls, audit trails, electronic records, and electronic signatures as applicable.
Lead root-cause analysis for validation failures, defects, and deviations and coordinate corrective actions with Quality, IT, vendors, and application teams.
Support change controls, system patches, version upgrades, configuration changes, and regression-testing assessments to maintain validated state.
Partner with system owners and technical teams during application implementation, configuration, testing, deployment, and production stabilization.
Support validation and testing of system integrations, interfaces, master data, workflows, and configuration.
Participate in system and vendor assessments and ensure third-party/SaaS solutions meet applicable quality and regulatory expectations.
Maintain validation documentation in tools such as Client ALM, Jira, JAMA Connect, QMS, and ServiceNow.
Provide validation support during regulatory inspections, internal audits, customer audits, and quality reviews.
Develop SOPs, work instructions, user guides, and training materials for validated systems.
Provide training and guidance to business users and project teams on CSV processes and regulatory requirements.
Lead validation governance using RACI, RAID logs, risk tracking, deviation management, and stakeholder reporting.
Coordinate validation activities across geographically distributed teams and global implementation sites.
Provide validation leadership during system go-live and ensure all required validation deliverables and deviations are appropriately completed or dispositioned before release.