About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
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.
What You'll Do
- 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
What We Look For
- 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
ECI is an equal opportunity employer.
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.