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Validation Engineer

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NTT DATA

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Location:
United States , Pittsburgh

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Category:
IT - Software Development

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Contract Type:
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Salary:

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Job Description:

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.

Job Responsibility:

  • 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

Requirements:

  • 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)
  • 4+ years of strong knowledge of 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

Nice to have:

  • 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)

Additional Information:

Job Posted:
April 27, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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