CSV Engineer

Neko Health is a Swedish healthcare technology company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Neko's vision is to shift healthcare from reactive treatment toward preventative health and early detection. This requires completely reimagining the patient's experience and incorporating the latest advances in sensors and AI. Neko Health has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is convenient and affordable for the public. The company is based in Stockholm, offering the Neko Body Scan experience at locations in Stockholm, London and Manchester, with over 500 employees.

About the Role

At Neko Health, we develop innovative medical technologies that enhance healthcare outcomes. As a Computer System Validation Engineer, you will execute validation activities for software tools and computer systems used across engineering, manufacturing, operations, and quality. You will ensure validation activities are planned, executed, and documented in compliance with medical device regulations, maintaining validated state for systems in scope while supporting business continuity and audit readiness.
More than just ticking compliance boxes, you'll champion a "quality beyond compliance" mindset that transforms validation activities into genuine business value. Your work will directly contribute to the company's success by ensuring our systems are not only compliant but also optimized for performance and efficiency, while helping to shape our future by innovating and developing our quality processes.

Responsibilities::
• Plan and execute validation activities for new and existing computer systems across all departments.
• 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 validation plans, protocols, reports, and supporting evidence.
• Conduct risk assessments and determine appropriate validation strategies based on system criticality and complexity.
• Coordinate validation activities with cross-functional teams including IT, Quality, Engineering, and Operations.
• Follow established validation processes and guidelines to ensure consistent, risk-based validation.
• Support validation of both purchased and internally-developed tools, including scripts, automation, and QMS-integrated solutions.
• Identify, document, and escalate validation issues, deviations, or risks in accordance with procedures.
• Support internal and external audits by providing validation evidence and addressing auditor requests.
• Provide feedback and suggestions to improve validation templates, processes, and tooling to reduce manual effort.
• Collaborate with system owners, IT, engineering, and quality stakeholders to ensure validation activities align with business needs.

Requirements::
• 5+ years of experience in computer system validation, software validation, or similar roles within the medical device, regulated, or life sciences industries.
• BSc or MSc in Computer Science, Engineering, Systems, or related technical discipline.
• Experience validating both commercially-purchased systems and internally-developed software (including scripts and automation).
• Working knowledge of regulatory requirements for system validation, including EU MDR (2017/745 Annex XI) and US FDA (21 CFR Part 820 and Part 11).
• Practical experience with CSV principles, risk-based validation approaches, and frameworks such as GxP, GAMP, and ISO/TR 80002-2.
• Experience working in agile development environments and applying iterative validation approaches that balance compliance with development velocity.
• Skilled at writing and executing validation protocols, test cases, and reports.
• Experience maintaining audit-ready documentation and supporting audit requests.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent written and verbal communication skills in English.

Nice to Have::
• Experience with cloud-based systems and SaaS validation in regulated environments.
• Hands-on experience with Azure DevOps and similar DevOps tools for validation workflow management and automation.
• Knowledge of automated testing tools and DevOps practices applied to validation.
• Familiarity with data integrity principles and practices (ALCOA+ principles).
• Active participation in professional organizations such as ISPE.
• Experience with agile validation approaches and CI/CD pipelines.

We offer a dynamic work environment with a high degree of autonomy that fosters growth and development. If you are passionate about building a better healthcare system for everyone and you thrive in a fast-paced environment, we would love to hear from you!

Please note: we perform background and reference checks as part of our interview process.