Location: Greater Boston, United States | Type: Remote | Country: USThe Computer System Validation (CSV) Specialist ensures computerized systems are validated, maintained, and operated in compliance with applicable regulatory requirements and industry best practices. The role serves as a subject matter expert in CSV, FDA 21 CFR Part 11, GxP, data integrity, and computerized system lifecycle management.The CSV Specialist partners with IT, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Quality Assurance, and external sponsors to validate systems supporting clinical research and maintain regulatory compliance, data integrity, audit readiness, and risk management.Essential ResponsibilitiesComputer System ValidationLead risk-based validation activities for GxP-regulated computerized systems.Develop and maintain validation documentation, including URS, specifications, risk assessments, traceability matrices, IQ/OQ/PQ protocols, and validation reports.Coordinate and execute validation testing in accordance with GAMP 5 and FDA expectations.Maintain validated systems through change control and lifecycle management.Regulatory Compliance & Risk ManagementEnsure compliance with FDA 21 CFR Part 11, GxP, ALCOA+ principles, GDPR, HIPAA, ICH E6(R3), and sponsor requirements.Assess electronic records, electronic signatures, audit trails, system changes, and data integrity controls.Conduct system risk assessments and develop appropriate mitigation and remediation plans.Cloud, SaaS & Microsoft TechnologiesValidate cloud-based, SaaS, and on-premises applications, including Microsoft 365, Azure, SharePoint, Teams, CTMS, EDC, eTMF, and QMS platforms.Review vendor validation packages and assess supplier compliance.Evaluate and support compliance controls using Microsoft Purview, Defender, Entra ID, Azure Monitor, and Log Analytics.Clinical Research & Data IntegrityValidate systems supporting clinical research, including CTMS, EDC, eTMF, safety, statistical, and reporting systems.Ensure data is accurate, complete, consistent, reliable, and traceable.Support data governance, audit trail monitoring, record retention, and regulatory compliance.Audits, Documentation & TrainingServe as the CSV subject matter expert during sponsor audits, regulatory inspections, quality audits, and vendor assessments.Provide validation and compliance documentation and support corrective actions.Develop validation procedures, work instructions, and templates.Train employees on validation and system compliance requirements.QualificationsEducationBachelor’s degree in information technology, Computer Science, Life Sciences, Quality Assurance, or a related field, or equivalent experience in a regulated industry.Experience5+ years of Computer System Validation experience in pharmaceutical, biotechnology, medical device, clinical research, healthcare technology, or a related regulated environment.Demonstrated experience validating GxP-regulated systems and supporting audits and regulatory inspections.Required Knowledge & SkillsFDA 21 CFR Part 11, GAMP 5, GxP, CSV methodologies, and risk-based validation.ALCOA+ data integrity principles, electronic records/signatures, audit trails, SDLC, change management, and quality systems.Microsoft 365, Microsoft Purview, SharePoint Online, Teams, Azure/Log Analytics, and data governance technologies.Preferred CertificationsCSV, CQA, ASQ, GAMP, CISA, or CIPP certification/training.
16 days ago