Computer Systems Validation Engineer

The posting, as Praxis Precision Medicines, Inc. wrote it

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, and evidence requirements based on intended use, patient safety, product quality, data integrity, and regulatory impact.
• Execute or coordinate qualification and verification activities, including installation, operational, performance, user acceptance, and other risk-based assurance testing.
• Assess changes to validated systems, determine validation impact, support appropriate regression testing, and ensure changes are implemented through approved change control procedures.
• Perform validation maintenance activities, including periodic reviews, access and audit-trail reviews as applicable, revalidation assessments, and retirement or decommissioning support.
• Support investigation and resolution of validation deviations, test exceptions, incidents, and compliance gaps, and contribute to corrective and preventive actions when appropriate.
• Prepare validation records and evidence packages for internal audits, partner audits, regulatory inspections, and d

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rapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust , Ownership , Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE ® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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