Your work will help ensure that Neko Health continues to build and operate safe, compliant, and high-quality systems, while raising both the quality and the velocity of how we work.

What You'll Deliver In The First 6–12 Months

• Complete your first validation projects end to end, establishing the controls, guardrails, and documented evidence that bring each system into a validated state and demonstrate it performs as intended.
• Use validation to drive process excellence, improving the systems and processes you touch, not only proving they are compliant.
• Act as the main point of contact for CSV and compliance questions on your assigned projects, with clear communication of quality and compliance risks.
• Ensure the systems you validate are audit- and inspection-ready, held in a validated, controlled state that consistently meets both regulatory expectations and our own internal standards.
• Demonstrate the impact of validation on both quality and business value, showing that strong validation accelerates delivery rather than slowing it down.
• Contribute to moving our CSV process towards an AI-first way of working, and to establishing internal standards for using AI while staying compliant.

Minimum Qualifications

• At least 5 years in computer system validation within medical devices, pharmaceuticals, or biotechnology.
• Deep understanding of the CSV lifecycle and the end-to-end validation process.
• Familiarity with modern CSV approaches, including the FDA's Computer Software Assurance (CSA).
• Strong grounding in risk management and risk management tooling.
• A learn-and-adapt mindset: you bring genuine depth in CSV, but you stay open to new approaches and ready to evolve how things are done here, rather than insisting on a single established way of working.
• Comfortable using AI as part of how you work day to day, and interested in applying it to improve compliance processes.
• Strong communication skills, with the ability to translate between regulatory needs and engineering practice, and between compliance and business language.
• Ability to work independently and take ownership in a fast-moving, frequently changing environment. Given the goal and the boundaries, you find your own way to deliver.
• Comfortable working remotely and as part of a distributed team most of the time.
• Fluent written and spoken English.

Preferred

• Hands-on experience applying AI in day-to-day practice, including implementing and validating AI-assisted workflows.
• Familiarity with regulatory frameworks such as ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, EU GMP, MDR, and GAMP 5.
• Experience with systems used in laboratory environments, for example LIMS, electronic lab notebooks (ELN), specimen management systems or other instrument data systems, and environmental or equipment monitoring systems.
• Experience with DevOps environments and tooling (e.g. Azure DevOps) and CI/CD pipelines.
• Scripting experience (e.g. Python or PowerShell).
• Experience working in fast-scaling organisations with evolving processes.

About Titles At Neko

We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process.

Hiring Process

Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team.

Equal Opportunity & Inclusion Statement

Neko Health is committed to inclusive hiring and member-first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.