Validation Engineer II
Core
Provide technical support for sterile packaging projects to ensure regulatory compliance and maintain quality standards across Medline product divisions.
Role type
Validation Engineer
Builds
Packaging validation processes and supplier improvement plans
Domain
Medical device manufacturing / Sterile packaging
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering principles, regulatory compliance knowledge, project management, conflict resolution, SOP development, corrective and preventative action (CAPA) implementation, technical training, audit/vigilance analysis, database management
Preferred skills
Medical device sterilization knowledge, quality system auditing, ISO13485, 21CFR820, 21CFR210/211
Technologies
None stated
Responsibilities
Develop and troubleshoot packaging validation processes, oversee validation development projects, provide technical training for junior members, manage supplier corrective actions, support FDA/Mock FDA projects, review and update packaging databases
Seniority
Mid-level (5+ years experience)
