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SW Tool Validation Lead

Neko Health· Legal
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Hybrid (Stockholm)Full-timePosted 4w ago

About the role

Lead the software tool validation and computer system validation (CSV) function end to end, including assurance approach, systems, and the CSV engineering team. Implement risk-based validation aligned with GAMP 5 and FDA guidance, handling AI-enabled tools, audits, and Notified Body assessments in a fast-moving, regulated medical environment.

Responsibilities

  • Act as process owner for software tool validation, setting the assurance approach and the standards the function works to.
  • Prioritise the tool estate by risk, allocating assurance effort according to patient safety, product quality and data integrity impact.
  • Design and run assurance activities yourself: map the process, identify the risks and requirements, test the system, and form your own evidence-based view before you approve anything.
  • Maintain the validated state of the estate as it changes, integrates, migrates and retires, running validation as a continuous activity rather than a periodic campaign.
  • Own how we assure AI-enabled tools and systems, where non-determinism, model updates and opaque supplier behaviour break the assumptions conventional validation rests on.
  • Own findings and issues across the estate, from honest impact assessment through containment to closure.
  • Lead and develop the CSV team, with clear system ownership and engineers who make and defend their own risk calls.
  • Represent the function in audits and Notified Body assessments, presenting and defending the assurance case for our systems.

Qualifications

  • 10+ years in computer system validation, software tool validation or software quality within medical device, pharmaceutical or another regulated industry.
  • BSc or MSc in Computer Science, Engineering, Information Systems or an equivalent technical discipline.

Skills

Required:Software tool validationComputer System Validation (CSV)Risk-based assuranceAI/ML validation in regulated contextLeadership/People managementAudits and Notified Body readinessRegulatory standards
Last updated Oct 23, 2026. Interested? Apply on the company site.
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