neko-health - CSV Engineering Lead

• 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. • 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.