Engineer - Validation
Core
Validating manufacturing processes and production units to ensure consistent quality product output and compliance with standards.
Role type
Validation Engineer
Builds
Medical device manufacturing processes for chronic condition management products
Domain
Medical devices / Advanced Wound Care / Ostomy Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, risk assessment (PFMEA), statistical analysis, root cause analysis, SOP compliance, machine card management
Preferred skills
QMS systems (ISO 13485, ISO 9001), cGMP understanding, Minitab, SAP, Master's degree in Engineering
Technologies
Minitab, SAP, Office (Excel, Word, PowerPoint)
Responsibilities
Outline validation steps based on process risks, re-validate processes according to time plans, review validation procedures, write validation documentation, update/create machine cards, support process failure investigations, provide regular updates to management
Seniority
Entry-level to Junior (1+ year experience required)
