Req ID: 392660
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 Lead Computer System Validation (CSV) Engineer - Hybrid to join our team in Pittsburgh, Pennsylvania (US-PA), United States (US).
Lead Computer System Validation (CSV) EngineerLocation: Pittsburgh, PA - Hybrid / Partially On-Site
Experience: 6+ Years
Industry: Life Sciences / Pharmaceutical / Biotechnology / Medical Devices
Position OverviewWe 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.
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.
Required Qualifications- 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.
Preferred ExperienceExperience 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)
Data Migration & IntegrationExperience 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
AI & Validation Automation - PreferredExperience 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.
Leadership & Core CompetenciesThe successful candidate will be able to:
- Own validation workstreams from strategy through go-live.
- Establish practical, risk-based validation approaches.
- Lead cross-functional validation teams and coordinate activities across multiple sites.
- Serve as a CSV subject-matter expert and trusted advisor to project and Quality teams.
- Guide junior validation engineers and testers.
- Manage vendors and external implementation partners.
- Clearly communicate validation risks, issues, and readiness to project and senior stakeholders.
- Support audit and inspection readiness.
- Provide sound, risk-based recommendations regarding system release and validated-state maintenance.
Pay TransparencyWhere required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting pay range for this remote role is $80,480-$114,000. This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on a number of factors, including the candidate's actual work location, relevant experience, technical skills, and other qualifications.
This position is eligible for company benefits including medical, dental, and vision insurance with an employer contribution, flexible spending or health savings account, life and AD&D insurance, short- and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally-required benefits.
About NTT DATANTT 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 part of NTT Group, which invests over $3 billion each year in R&D.
Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client's needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, ;br>
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