Sign upLog in

Instrument Software Validation Analyst

NTT DATA

Cincinatti, OH

Apply
JOB DETAILS
SALARY
$45–$53 Per Hour
SKILLS
Analysis Skills, Artificial Intelligence (AI), Biology, Biotech and Pharmaceutical, Change Control, Change Management, Code of Federal Regulations, Computer Science, Computer Skills, Computer Systems, Consulting, Cross-Functional, Customer/Client Research, Data Quality, Detail Oriented, Documentation Standards, Ecosystems, Embedded Software, Embedded Systems, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Functional Testing, GxP, Identify Issues, Information Technology Software, Integration Testing, Laboratory Analysis, Maintain Compliance, Manufacturing, Manufacturing Software, Medical Equipment, Problem Solving Skills, Procedure Implementation, Process Validation, Quality Assurance, Regression Testing, Regulations, Regulatory Compliance Software, Regulatory Requirements, Requirements Management, Research & Development (R&D), Risk Analysis, Risk Management, Root Cause Analysis, Software Administration, Software Development, Software Specification, Software Testing, Software Validation, Standard Operating Procedures (SOP), Startup, System Lifecycle, System Operations, System Validation, Systems Administration/Management, Systems Maintenance, Technical Writing, Technical/Engineering Design, Test Case, Traceability, Validation Documentation, Validation Plan, Validation Testing, Writing Skills
LOCATION
Cincinatti, OH
POSTED
30+ days ago
Company Overview:
Req ID: 370118
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.
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. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at us.nttdata.com


NTT DATA endeavors to make https://us.nttdata.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at https://us.nttdata.com/en/contact-us. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. 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. For our EEO Policy Statement, please click here. If you'd like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.

About the Company

N

NTT DATA

NTT DATA means Business

NTT DATA is your Innovation Partner anywhere around the world. With business operations in more than 50 countries, we put emphasis on long-term commitment and combine global reach and local intimacy to provide premier professional services from consulting, system development, business process and IT outsourcing, to cloud-based solutions.

NTT DATA Americas' Strategic Staffing group provides our clients with top notch technical talent to augment their core IT staff. Our approach is customer centric, partnering to assist you in achieving your strategic goals and IT initiatives. We get to know your company’s culture and the type of technical staff that thrive within your organization. We understand your specific technical and business requirements, timing, and budget.

  • NTT DATA is part of the NTT Group – a Fortune 31 Global IT & Telecom services company.
  • NTT Group one of the largest Telecommunications Companies in the world.
  • NTT DATA is ranked in the top 10 largest global IT services provider in the world.
Collectively, the integrated company generates $16B in annual revenues with over 130,000 employees across 50 countries Visit www.nttdata.com/americas to learn how our consultants, projects, managed services, and outsourcing engagements deliver value for a range of businesses and government agencies.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
Retirement / Pension Plans
FOUNDED
1967
WEBSITE
http://americas.nttdata.com/Careers/Careers.aspx

Resume Resources

Free Resume TemplatesFree Resume Builder