Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.
The OpportunityPraxis 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
