What are the responsibilities and job description for the Validation Engineer position at NTT DATA, Inc.?
Req ID: 367853
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 Validation Engineer to join our team in Pittsburgh, Pennsylvania (US-PA), United States (US).
Job Title: Validation Engineer – Healthcare Domain
Experience: 4 Years
Employment Type: Full-time
Job Summary
We are seeking an experienced Validation Engineer with a strong background in the healthcare domain to ensure that systems, software, and processes meet regulatory and quality standards. The ideal candidate will have hands-on experience in validation activities aligned with GxP and other regulatory requirements, ensuring compliance and high-quality deliverables.
Key Responsibilities
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 Validation Engineer to join our team in Pittsburgh, Pennsylvania (US-PA), United States (US).
Job Title: Validation Engineer – Healthcare Domain
Experience: 4 Years
Employment Type: Full-time
Job Summary
We are seeking an experienced Validation Engineer with a strong background in the healthcare domain to ensure that systems, software, and processes meet regulatory and quality standards. The ideal candidate will have hands-on experience in validation activities aligned with GxP and other regulatory requirements, ensuring compliance and high-quality deliverables.
Key Responsibilities
- Develop, review, and execute validation deliverables including:
- Validation Plans (VP)
- User Requirement Specifications (URS)
- Functional/Design Specifications (FS/DS)
- IQ/OQ/PQ protocols and reports
- Perform computer system validation (CSV) for healthcare/medical applications
- Ensure compliance with FDA 21 CFR Part 11, GAMP 5, HIPAA, and other applicable regulations
- Conduct risk assessments and validation impact analysis
- Collaborate with cross-functional teams (QA, IT, Regulatory, Business)
- Support audit readiness and participate in internal/external audits
- Manage deviations, CAPA, and change controls related to validation activities
- Maintain validation documentation lifecycle in accordance with SOPs
- Provide validation support for software upgrades, implementations, and integrations
- Bachelor’s degree in Engineering, Life Sciences, or related field
- 4 years of experience in validation within healthcare, pharma, or medical devices domain
- 4 years of strong knowledge of:
- CSV (Computer System Validation)
- FDA regulations & ISO standards (e.g., ISO 13485)
- 4 years of experience with validation tools and documentation practices
- Good understanding of SDLC and Agile methodologies
- Strong analytical, documentation, and communication skills
- Experience with LIMS, EMR/EHR systems, or clinical applications
- Familiarity with automation validation tools
- Certification in GAMP, Six Sigma, or Quality Assurance
- Exposure to cloud-based healthcare systems validation (AWS, Azure)
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.