CSV Engineering Lead

Neko Health

CSV Engineering Lead ensuring compliance and validation of healthcare systems. Driving process improvement and AI integration in validation workflows.

Posted 7/2/2026full-timeNew York City • New York • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Health insurance
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CSV Lifecycle ManagementEnd-to-End Validation ProcessRisk Management ToolingValidation Controls and GuardrailsAudit and Inspection Readiness

Soft Skills

Learn-and-Adapt MindsetOwnership in Fast-Moving EnvironmentsIndependent Work CapabilityClear Communication