Computer Systems Validation Engineer
Praxis Precision Medicines, Inc.
August 21, 2026
Remote friendly (Boston, MA)
United States
IT
Primary Responsibilities
- Lead and scale Computer System Validation (CSV) capability across IT: define validation strategy, operating model, standards, and risk-based approach; build and develop the CSV team.
- Author, review, execute, and maintain CSV lifecycle deliverables (validation plans, requirements, risk assessments, design/config specs, test protocols/scripts, traceability matrices, validation summary reports).
- Build/develop CSV team (hiring, onboarding, mentoring, developing CSV Engineers).
- Use documented, risk-based approach to determine validation scope, test depth, and evidence requirements (intended use, patient safety/product quality, data integrity, regulatory impact).
- Execute/coordinate qualification & verification (installation, operational, performance, user acceptance, other risk-based assurance testing).
- Assess validated system changes; determine validation impact; support regression testing; ensure changes follow approved change control.
- Perform validation maintenance (periodic reviews, access/audit-trail reviews as applicable, revalidation assessments, retirement/decommissioning support).
- Support deviation/test exception/incident resolution; contribute to CAPA.
- Prepare validation records/evidence packages for audits, inspections, due diligence.
- Collaborate with owners/Quality/IT/technical teams/vendors to deliver practical, scalable validation strategies.
- Continuously improve procedures, templates, standards, metrics, and training; use approved automation/AI tools with independent review.
Qualifications and Key Success Factors
- BS in engineering/CS/IS/life sciences (or equivalent experience).
- Significant regulated-industry experience (biotech/pharma/medical devices/healthcare).
- Strong CSV, Computer Software Assurance, quality systems, and data integrity knowledge.
- Ability to lead validation across multiple systems/projects.
- Experience with regulatory inspections/audits/validation assessments and quality documentation.
- Strong GxP knowledge (GAMP 5, risk-based CSV/CSA; 21 CFR Part 11, EU Annex 11 as applicable; ALCOA+; change control, deviations, CAPA, document control).
- Experience with functional risk assessments, traceability, supplier assessments, periodic review.
- Experience with IQ/OQ/PQ/UAT (or equivalent).
- Scripting, SQL, test/validation automation, eDMS, quality/issue-tracking tools (advantageous).
- Travel as needed; remote possible.
- Lead and scale Computer System Validation (CSV) capability across IT: define validation strategy, operating model, standards, and risk-based approach; build and develop the CSV team.
- Author, review, execute, and maintain CSV lifecycle deliverables (validation plans, requirements, risk assessments, design/config specs, test protocols/scripts, traceability matrices, validation summary reports).
- Build/develop CSV team (hiring, onboarding, mentoring, developing CSV Engineers).
- Use documented, risk-based approach to determine validation scope, test depth, and evidence requirements (intended use, patient safety/product quality, data integrity, regulatory impact).
- Execute/coordinate qualification & verification (installation, operational, performance, user acceptance, other risk-based assurance testing).
- Assess validated system changes; determine validation impact; support regression testing; ensure changes follow approved change control.
- Perform validation maintenance (periodic reviews, access/audit-trail reviews as applicable, revalidation assessments, retirement/decommissioning support).
- Support deviation/test exception/incident resolution; contribute to CAPA.
- Prepare validation records/evidence packages for audits, inspections, due diligence.
- Collaborate with owners/Quality/IT/technical teams/vendors to deliver practical, scalable validation strategies.
- Continuously improve procedures, templates, standards, metrics, and training; use approved automation/AI tools with independent review.
Qualifications and Key Success Factors
- BS in engineering/CS/IS/life sciences (or equivalent experience).
- Significant regulated-industry experience (biotech/pharma/medical devices/healthcare).
- Strong CSV, Computer Software Assurance, quality systems, and data integrity knowledge.
- Ability to lead validation across multiple systems/projects.
- Experience with regulatory inspections/audits/validation assessments and quality documentation.
- Strong GxP knowledge (GAMP 5, risk-based CSV/CSA; 21 CFR Part 11, EU Annex 11 as applicable; ALCOA+; change control, deviations, CAPA, document control).
- Experience with functional risk assessments, traceability, supplier assessments, periodic review.
- Experience with IQ/OQ/PQ/UAT (or equivalent).
- Scripting, SQL, test/validation automation, eDMS, quality/issue-tracking tools (advantageous).
- Travel as needed; remote possible.