Instrument Software Validation Analyst

Company Overview

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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.

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.

• 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

• 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

• Gather and document system requirements
• Develop software specifications and validation test cases
• Create infrastructure diagrams and data flow documentation
• Document current‑state software configurations

• 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

• 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

• 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)

• 5+ years of strong understanding of FDA, EMA, and GMP regulations
• 21 CFR Part 11
• GAMP 5 guidelines
• Data integrity principles

• 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

• 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

• Experience in global regulatory environments
• Exposure to instrument software in laboratory or manufacturing settings
• Knowledge of SOP migration and system lifecycle management

The starting hourly range for this role is USD $45.00 to $50.00 per hour
. 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 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 401(k) program with company match, and additional voluntary or legally required benefits.

NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.