CSV Engineering Lead

Neko Health • New York, NY

1d • Remote

About The Position

Mission Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. As a CSV Engineering Lead, you will make sure the systems Neko relies on are validated, fit for their intended use, and backed by documented evidence that they perform as expected. You will ensure these systems meet the regulatory requirements of the markets we operate in, across the US and Europe, and that they stay in a controlled, compliant state over time. In this role you will lead and drive validation forward, taking ownership of the projects you are assigned and moving them from planning through to a validated, defensible end state. You will be the main point of contact for CSV and compliance questions on those projects, translating regulatory expectations into practical validation activities that the rest of the organisation can work with. Computer system validation at Neko is not only about compliance. It is equally about making our systems and processes better. You will use validation to drive process excellence and improvement, raising the quality and reliability of how we work, not just proving that we meet the rules. You will also actively improve how we run CSV itself. You will help move our CSV process towards an AI-first approach, and, together with the CSV team, contribute to establishing internal standards for how we use AI while staying compliant. You will be working alongside colleagues whose experience and views vary, so a readiness to learn, adapt, and shape the right approach together matters as much as the expertise you bring. 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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed