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Numbers Only Inc Logo Numbers Only Inc · IT - Software Development

Validation Engineer / Business Analyst

· Job Posted February 14, 2026
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Job Description

We are seeking a Validation Engineer / Business Analyst to support GxP-regulated systems across Manufacturing, Quality, and R&D. This role will lead Computer System Validation (CSV/CSA) activities while partnering with cross-functional teams to gather requirements, ensure regulatory compliance, and maintain audit readiness.

Job Responsibility

  • Execute validation lifecycle activities (VP, IQ/OQ/PQ, RTM, VSR/TSR)
  • Ensure compliance with FDA 21 CFR Part 11, Part 820, ISO 13485, and EU Annex 11
  • Gather and document business requirements
  • translate into testable system specifications
  • Support MES, eQMS, and Non-Product Software validation and change control
  • Maintain audit-ready documentation and support internal/external audits
  • Assist with CAPA, non-conformance, and risk management activities

Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred)
  • 3+ years of experience in Medical Device/Pharma regulated environments
  • Hands-on experience in CSV/CSA and validation documentation
  • Familiarity with eQMS platforms (Veeva, ETQ, Arena or similar)
  • Strong knowledge of FDA regulations and ISO 13485
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