Praxis Precision Medicines
Lead Computer System Validation Engineer
RemoteUnited States only
- Experience
- Lead
- Employment
- Full-time
$150k–$178k/yr
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Open to US only. Set where you work from to check your eligibility.
No BS summary
Lead Computer System Validation Engineer with experience in biotech/pharma/medical device/healthcare. Must have strong CSV, CSA, quality systems, and data integrity knowledge. Will lead validation strategy, build the CSV team, and partner with various departments. Requires a Bachelor's degree or equivalent experience.
Core skills
Computer System ValidationGxP
Required skills
Computer Software Assurancequality systemsdata integrityGxP requirementsGAMP 5risk-based CSV/CSA principles21 CFR Part 11EU Annex 11ALCOA+ data integrity principleschange controldeviationsCAPAdocument controlfunctional risk assessmentsrequirements of traceabilitysupplier assessmentsperiodic reviewIQOQPQUAT
Optional skills
scriptingSQLtest automationvalidation automationelectronic document managementquality managementissue-tracking tools
Required languages
English
What you'll do
- 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.
What they require
- 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.
- 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.
Benefits
- 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.
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.
$150k–$178k/yr