What are the responsibilities and job description for the Instrument Software Validation Analyst position at NTT DATA, Inc.?
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.
We are currently seeking a Instrument Software Validation Analyst to join our team in Cincinnati, Ohio (US-OH), United States (US).
Job Title: Instrument Software Validation Analyst
Location - Work from client office - 2110 East Galbraith Road, Cincinnati, OH 45237
Overview
We are 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
Regulatory Knowledge
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 a 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, https://us.nttdata.com/en/contact-us.
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.
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 Instrument Software Validation Analyst to join our team in Cincinnati, Ohio (US-OH), United States (US).
Job Title: Instrument Software Validation Analyst
Location - Work from client office - 2110 East Galbraith Road, Cincinnati, OH 45237
Overview
We are 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
- 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)
Regulatory Knowledge
- 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
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 a 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, https://us.nttdata.com/en/contact-us.
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.