---
title: 'Computer Systems Validation Engineer at Praxis Precision Medicines, Inc.'
canonical: 'https://feeny.ai/job/computer-systems-validation-engineer-praxis-precision-medicines-inc-united-84kqsazb917h'
type: 'job'
last_seen: '2026-09-06'
---

# Computer Systems Validation Engineer at Praxis Precision Medicines, Inc. 

- **Company:** Praxis Precision Medicines, Inc. 
- **Location:** United States
- **Compensation:** $150k–$178k
- **Work type:** remote
- **Posted:** 2026-08-21
- **Last confirmed live:** 2026-09-06
- **Apply:** https://job-boards.greenhouse.io/praxisprecisionmedicines/jobs/5381254008

## Job description

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, 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 due-diligence activities.
- Collaborate with system owners, business process owners, Quality, IT, technical teams, and vendors to translate business and compliance needs into practical, scalable validation strategies and executable deliverables.
- Own and continuously improve validation procedures, templates, standards, metrics, and training materials, establishing an approach appropriate for a lean and rapidly growing biotechnology organization.
- Use automation and AI-assisted tools, where approved, to improve validation efficiency while ensuring outputs are independently reviewed for accuracy, completeness, and compliance.

## Qualifications and Key Success Factors

- Bachelor's degree in engineering, computer science, information systems, life sciences, or a related discipline; equivalent relevant experience may be considered.
- Significant experience working in biotechnology, pharmaceutical, medical device, healthcare, or another regulated environment.
- Strong experience with Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles.
- Demonstrated ability to lead validation activities across multiple computerized systems and projects, including setting validation strategy and providing direction to technical and business teams.
- Experience supporting regulatory inspections, audits, validation assessments, and quality-system documentation.
- Strong knowledge of GxP requirements, GAMP 5 and risk-based CSV/CSA principles, 21 CFR Part 11 and EU Annex 11 as applicable, ALCOA+ data integrity principles, and quality processes including change control, deviations, CAPA, and document control.
- Experience with functional risk assessments, requirements of traceability, supplier assessments, change control, deviations, CAPA, and periodic review.
- Experience authoring, reviewing, or executing IQ, OQ, PQ, UAT, or equivalent risk-based verification documentation.
- Familiarity with scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools is advantageous.
- The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices, or other office equipment, clear communication, and occasional movement. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Annualized Base Salary $150,000—$178,000 USD

## Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together!

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies 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.

Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com.

Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

## About Praxis Precision Medicines, Inc. 

## Company Overview
- **One-liner**: Praxis Precision Medicines is a fully integrated, clinical-stage biopharmaceutical company developing precision therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance.
- **Entity Type**: Public (NASDAQ: PRAX)
- **Headquarters**: Boston, Massachusetts, United States
- **Founded**: 2015
- **Founders**: Dr. Steven Petrou (Co-Founder and President of R&D)

## Core Business
- **Primary Industry**: Biotechnology (CNS / Neuroscience)
- **Target Customers**: Patients with rare and prevalent neurological disorders (e.g., essential tremor, developmental and epileptic encephalopathies, focal epilepsy); healthcare providers; payers.
- **Mission / Purpose**: To translate genetic insights into the development of life-altering therapies for CNS disorders more effectively and efficiently.

## Products & Services
Praxis operates two proprietary platforms and a pipeline of late-stage and early-stage programs:
- **Cerebrum™ (Small Molecule Platform)**: Orally available precision therapies targeting ion channels and neuronal circuits. Key assets include:
    - **Ulixacaltamide**: A T-type calcium channel inhibitor for essential tremor (ET). NDA submission to the FDA expected by mid-February 2026. Breakthrough Therapy Designation.
    - **Relutrigine**: For SCN2A- and SCN8A-developmental and epileptic encephalopathies (DEEs). NDA submission expected by mid-February 2026. Breakthrough Therapy Designation. Also in Phase 3 for broad DEEs.
    - **Vormatrigine**: A sodium-channel modulator for focal onset seizures (FOS). In Phase 3 trials (POWER1, POWER2).
- **Solidus™ (Antisense Oligonucleotide Platform)**: For genetically defined CNS disorders. Key asset:
    - **Elsunersen**: An ASO designed to reduce SCN2A gene expression for early-seizure-onset SCN2A-DEE. In Phase 3 (EMBRAVE3). Orphan Drug Designation.
- **Early-Stage Pipeline**: Preclinical candidates (PRAX-020, PRAX-080, PRAX-090, PRAX-100) targeting other genetic epilepsies and neurodevelopmental disorders.

## Market Standing
- **Market Cap**: ~$156.0 million (as of mid-2026 data) [linkedin.com]
- **Key Metric (Revenue/Funding)**: Annual revenue reported at ~$8.6M (pre-commercial stage). Pro forma cash, cash equivalents, and marketable securities stand at **$1.5 billion** following a public offering in January 2026 that raised ~$621 million [ir.praxismedicines.com].
- **Notable Investors/Partners**: Ionis Pharmaceuticals, Inc. (collaboration on elsunersen); RogCon, Inc. (license agreement).
- **Growth Signals**:
    - Rapidly scaling headcount: 166 employees (+49.7% year-over-year) [linkedin.com].
    - Transformation to a commercial-stage company: Preparing for two NDA submissions by mid-February 2026.
    - Combined peak revenue estimates for its four late-stage assets expected to exceed **$20 billion** [ir.praxismedicines.com].
    - Active hiring: 31 open positions in mid-2026 (up 933% year-over-year) [linkedin.com].

## Competitive Advantages
- **Precision Neuroscience Moat**: Deep understanding of shared biological targets and circuits in the brain derived from genetic epilepsies.
- **Proprietary Dual Platforms**: Leveraging both small molecule (Cerebrum) and ASO (Solidus) modalities to address a wide range of CNS disorders.
- **Breakthrough Therapy Designations**: Both lead assets (ulixacaltamide, relutrigine) have FDA Breakthrough Therapy Designation, accelerating development and review.
- **Strong Cash Position**: $1.5 billion pro forma cash provides a long runway through multiple potential product launches and pipeline expansion.
- **Late-Stage Pipeline**: Four late-stage product candidates approaching potential commercial launch, de-risking the company substantially.

## Strategic Focus
- **Commercial Launch Readiness**: Building out commercial infrastructure, sales force, and patient support programs in parallel with regulatory submissions.
- **Pipeline Expansion**: Declaring multiple new drug candidates from both Cerebrum and Solidus platforms in 2026.
- **Lifecycle Management**: Exploring indication expansion for existing assets (e.g., relutrigine in broad DEEs via the EMERALD study; vormatrigine for monotherapy FOS).
- **Global Reach**: Operating in 5 countries (US, Australia, India, Colombia, Brazil) with a growing workforce.

## Why Work Here
- **Mission-Driven Work**: Opportunity to deliver transformative therapies to patients with severe, underserved CNS disorders.
- **Growth Trajectory**: The company is at a pivotal inflection point, transitioning from a clinical-stage to a commercial-stage organization — offering dynamic career growth.
- **Remote-First Culture**: The vast majority of open positions across all departments (Clinical, Medical, Commercial, Finance, Legal, etc.) are listed as **"United States - Remote"** [greenhouse.io]. This includes roles like Director, Commercial Compliance; Senior Clinical Trial Manager; and Director, Field Reimbursement.
- **Global Talent**: Engineering and technical roles are open internationally (e.g., Software Engineer in Brazil) [greenhouse.io].
- **Strong Leadership**: Recent appointments of experienced pharmaceutical executives (Jeffrey B. Kinder, Stuart Arbuckle) and internal promotions (Megan Sniecinski to COO).
- **Compensation**: Employee reviews indicate a strong **Compensation rating of 4.0/5.0**, though overall culture and career ratings are lower (2.8 and 2.7 respectively on LinkedIn) [linkedin.com].
- **Workforce Demographics**: A high proportion of Director-level roles are open (20% of workforce), alongside specialists and senior IC roles, suggesting significant opportunities for leadership-level hires.

## Sources
1. [greenhouse.io](http://job-boards.greenhouse.io/praxisprecisionmedicines) - Jobs at Praxis Precision Medicines, Inc.
2. [ir.praxismedicines.com](https://ir.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-enters-its-next-chapter-following) - Press Release: Business Outlook and Priorities for 2026
3. [linkedin.com](https://www.linkedin.com/company/praxis-precision-medicines-inc) - LinkedIn Company Profile
4. [stockanalysis.com](https://stockanalysis.com/stocks/prax/company/) - Company Profile & Key Executives

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