JOB DESCRIPTION
Req ID: 367853
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
Required Skills & Qualifications
- 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
Preferred Qualifications
- 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)
About NTT DATA
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.