Req ID:
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) Engineer
Location:
Pittsburgh, PA — Hybrid / Partially On-Site
Experience:
6+ Years
Industry:
Life Sciences / Pharmaceutical / Biotechnology / Medical Devices
Position Overview
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.
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 Experience
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)
Data Migration & Integration
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
AI & Validation Automation — Preferred
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.
Leadership & Core Competencies
The 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 Transparency
Where 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 DATA
NTT 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 @ and @ email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form,
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