Computer System Validation Engineer

About the Role

Join Neko Health, a pioneering health-tech company, to ensure our innovative medical scanning technologies meet the highest regulatory standards by leading computer system validation activities across engineering and quality functions.

Responsibilities

• Plan and execute validation activities for new and existing computer systems across all departments (engineering, manufacturing, operations, quality).
• Develop and execute validation protocols, test cases, and traceability matrices for software tools and systems under scope.
• Prepare and maintain audit-ready validation documentation, including plans, protocols, and reports.
• Conduct risk assessments to determine appropriate, risk-based validation strategies based on system criticality.
• Support validation of both commercially-purchased systems and internally-developed software, including scripts and automation.
• Provide feedback to improve validation templates, processes, and tooling to reduce manual effort.
• Support internal and external audits by providing validation evidence and addressing auditor requests.

Requirements

• 5+ years of experience in computer system validation or software validation within the medical device, regulated, or life sciences industries.
• BSc or MSc in Computer Science, Engineering, Systems, or a related technical discipline.
• Practical experience with CSV principles, risk-based validation approaches, and frameworks such as GxP, GAMP, and ISO/TR 80002-2.
• Working knowledge of regulatory requirements, including EU MDR (2017/745 Annex XI) and US FDA (21 CFR Part 820 and Part 11).
• Experience applying iterative validation approaches in agile development environments.
• Strong analytical skills with meticulous attention to detail in documentation.
• Excellent written and verbal communication skills in English.

Nice-to-Haves

• Experience validating cloud-based systems and SaaS solutions in regulated environments.
• Hands-on experience with Azure DevOps or similar DevOps tools for workflow management.
• Familiarity with data integrity principles (ALCOA+).
• Knowledge of automated testing tools applied to validation processes.