Non-Product Software Validation Engineer
Core
Develop, review, and approve validation plans, protocols, scripts, and reports for computerized systems and AI/Machine Learning Validation to ensure compliance with regulatory requirements.
Role type
Software Validation Engineer (Regulated Industries)
Builds
Validation documentation and testing coverage for computerized systems and AI/ML models
Domain
Medical Devices, Pharmaceuticals, Automotive
Deliverable
production ML models | dashboards & analysis
Required skills
Computerized Systems Validation (CSV), Risk-based validation methodologies, Regulatory compliance knowledge, Technical writing, Data analysis, Project management
Preferred skills
AI/Machine Learning validation concepts, CAPA management, Process improvement
Technologies
None explicitly stated
Responsibilities
Develop and approve validation plans and protocols, Conduct risk assessments to determine validation scope, Evaluate system changes for validation impact, Assist with CAPAs related to computerized systems
Seniority
Mid-level, hands-on IC