Process Engineer Sterilisation
Core
Implement, maintain, and optimize pharmaceutical/biological manufacturing processes in a regulated environment to ensure safe, compliant, and efficient production.
Role type
Process Engineer (Sterilisation)
Builds
FreeStyle blood glucose test strips and FreeStyle Sensors for diabetes management
Domain
Healthcare / Medical Devices / Diabetes Care
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process optimization, process modeling, root cause analysis, CAPA management, GMP compliance, technical documentation, cross-functional collaboration
Preferred skills
electron beam sterilization, gamma sterilization, ISO 11137 knowledge
Technologies
electron beam, gamma irradiation
Responsibilities
Develop process flow diagrams and equipment specifications, monitor critical process parameters (temperature, pressure, density, viscosity, flow rates), lead root cause investigations using 5 Whys/DMAIC/Fishbone/FMEA, support commissioning, qualification, and validation activities, identify opportunities for cost reduction and yield improvement
Seniority
Mid-level, hands-on IC
