Validation Specialist IS (GxP) -CDI- F/M
Core
Ensure GxP Information Systems (on-premise and cloud) are validated, compliant, and maintained in a validated state throughout their lifecycle for R&D Pharma systems.
Role type
Validation Specialist IS (GxP)
Builds
Validated GxP systems for R&D Pharma, including cloud-based platforms (AWS/Azure) and automated validation pipelines.
Domain
Pharmaceutical R&D / GxP Compliance / Cloud Infrastructure
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, Annex 11, Cloud system validation (IaaS/PaaS/SaaS), Scripted and automated validation, Risk assessment, Change impact analysis, Vendor validation assessment, ALM tools, Audit trail review
Preferred skills
AWS or Azure experience, CI/CD pipeline validation, Business Continuity validation, CAPA management
Technologies
AWS, Azure, ALM tools
Responsibilities
Apply and maintain Group IS validation framework, Conduct risk assessments and impact analyses, Define risk-based validation strategies for cloud environments, Ensure ongoing compliance through change and incident assessments, Create and maintain validation documentation, Support internal and regulatory audits
Seniority
Mid-Senior, hands-on IC