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Company Overview:
Req ID: 370118
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NTT DATA's Client is currently seeking an Instrument Software Validation Analyst to join their team in Cincinnati, Ohio (US-OH), United States (US).
Overview
NTT DATA's Client is seeking an experienced Instrument Software Validation Analyst to ensure that laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between technical software testing and regulatory compliance.
Key Responsibilities
Software Validation & Compliance
Validate software installed on laboratory and manufacturing instruments in compliance with EMA, FDA, and GxP guidelines
Develop and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
Ensure systems remain in a validated state throughout their lifecycle
Documentation & Regulatory Support
Author and maintain validation documentation including:
Validation Plans and Reports
User Requirement Specifications (URS)
Functional/Design Specifications
Traceability Matrices
Ensure compliance with 21 CFR Part 11, GAMP 5, and data integrity standards
System Analysis & Design
Gather and document system requirements
Develop software specifications and validation test cases
Create infrastructure diagrams and data flow documentation
Document current-state software configurations
Testing & Execution
Perform functional, integration, regression, and data integrity testing
Identify, document, and troubleshoot validation deviations
Conduct root cause analysis and collaborate with cross-functional teams to resolve issues
Risk & Change Management
Conduct risk assessments (e.g., FMEA) to identify and mitigate system risks
Support and implement change control procedures for software updates and enhancements
Transition legacy SOPs to updated IT software management SOPs
Required Qualifications
Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field
Experience: 2–5+ years of experience in Computer System Validation (CSV) or software validation in regulated industries (pharmaceutical, biotech, or medical devices)
Required Skills & Competencies
Regulatory Knowledge
5+ years of strong understanding of:
FDA, EMA, and GMP regulations
21 CFR Part 11
GAMP 5 guidelines
Data integrity principles
Technical Expertise
3 to 5 years of experience with:
Laboratory systems such as LIMS
Chromatography Data Systems (e.g., Empower)
Familiarity with validation lifecycle and documentation standards
Core Competencies
Strong analytical and problem-solving skills
Excellent technical writing and documentation abilities
Attention to detail with a quality-focused mindset
Ability to work cross-functionally with IT, QA, and business teams
Preferred Qualifications
Experience in global regulatory environments
Exposure to instrument software in laboratory or manufacturing settings
Knowledge of SOP migration and system lifecycle management
About NTT DATA:
Where required by law, NTT DATA provides a reasonable range of compensation for specific roles

The starting hourly range for this role is Hourly rate $45.00hr to $50.00/hr. Actual compensation will depend on several factors, including the candidate’s relevant experience, technical skills, and other qualifications.
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, 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.
NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success

As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world.

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