Computer Software Assurance SME - Medical Device

About the Role

The Computer Software Assurance (CSA) Subject Matter Expert (SME) is responsible for leading and supporting risk-based software assurance and validation activities for GxP-regulated computerized systems. This role ensures compliance with regulatory requirements while promoting efficient CSA methodologies aligned with current U.S. Food and Drug Administration guidance, GAMP 5 principles, and data integrity expectations. The CSA SME collaborates with Quality, IT, Validation, Engineering, Manufacturing, Laboratory, and Business stakeholders to implement compliant and scalable software assurance practices across the system lifecycle.

• Lead implementation of Computer Software Assurance (CSA) methodologies across GxP systems
• Transition traditional CSV practices to risk-based CSA approaches
• Ensure compliance with:
  • 21 CFR Part 11
  • Annex 11
  • GAMP 5
  • FDA CSA guidance
  • Data Integrity (ALCOA+) principles
• Interpret regulatory requirements and provide compliance guidance to project teams
• Perform system risk assessments and determine appropriate assurance strategies
• Define intended use and critical functionality for computerized systems
• Develop and review:
  • Validation plans
  • Risk assessments
  • Test strategies
  • Traceability matrices
  • Summary reports
• Ensure testing activities focus on patient safety, product quality, and data integrity risks
• Support computerized system implementation and upgrades
• Participate in requirements gathering, design reviews, configuration reviews, user acceptance testing (UAT), change control assessments
• Support internal and external audits and regulatory inspections
• Review deviations, CAPAs, and change controls related to computerized systems
• Maintain inspection-ready validation documentation
• Collaborate with QA, IT, Automation, Engineering, and Operations teams
• Promote adoption of streamlined risk-based validation practices

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, Information Systems, or related field
• 5+ years of experience in:
  • Computer System Validation (CSV)
  • Computer Software Assurance (CSA)
  • GxP-regulated environments
• Strong knowledge of:
  • FDA regulations
  • GAMP 5
  • 21 CFR Part 11
  • SDLC methodologies
  • Risk management principles
• Experience validating:
  • SaaS/cloud platforms
  • Laboratory systems
  • Manufacturing systems
  • Enterprise applications
• Excellent documentation, communication, and stakeholder management skills

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. All candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship from ECI another 3rd party vendor.