Computer Systems Validation Engineer

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale.

This is a builder role: you’ll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

You’ll partner closely with Quality, IT, business process owners, vendors, and technical teams to lead validation across multiple computerized system initiatives.

We’ll count on you to bring deep lifecycle expertise, sound judgment, and a willingness to ask whether there’s a better way—balancing compliance and data integrity with business needs, risk, and speed. You’ll thrive here if you take ownership, question unnecessary complexity, and turn ambiguity into practical solutions.

We’re looking for someone who can maintain a high bar for quality without defaulting to process for process’s sake—and who wants to build approaches that help Praxis move faster and with confidence as we work to deliver meaningful medicines to patients.

Primary Responsibilities Lead and scale the Computer System Validation capability across IT, defining the validation strategy, operating model, standards, and risk-based approach while building and developing the CSV team as Praxis grows.

Author, review, execute, and maintain validation lifecycle deliverables, including validation plans, requirements, risk assessments, configuration or design specifications, test protocols and scripts, traceability matrices, and validation summary reports.

Build and develop the CSV team over time as the GxP technology portfolio and organizational needs grow, including hiring, onboarding, mentoring, and developing additional CSV Engineers. Apply a documented, risk-based approach to determine validation scope, test depth