Operations Scientist - Analytical Method Validation
Core
Lead analytical test method validation, laboratory equipment/software qualification, and cleaning validation to support manufacturing of glucose monitoring systems.
Role type
Operations Scientist (Analytical Method Validation)
Builds
Validated analytical methods, qualified lab equipment/software, and compliant cleaning processes for medical device manufacturing.
Domain
Medical Devices / Diabetes Care / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical test method validation, FMEA, Critical Quality Attributes (CQA), risk assessment, regulatory guideline adherence, procedure writing, calibration management, data analysis, report writing, hands-on practical skills, IT skills (Excel, PowerPoint)
Preferred skills
Experience with laboratory equipment/software validation, cleaning validation, cross-functional collaboration
Technologies
Laboratory equipment, software validation tools, Excel, PowerPoint
Responsibilities
Create test method validation documentation (protocols, FMEA, CQAs), perform impact risk assessments and corrective actions, support lab instrument software and cleaning validation, maintain laboratory controls and calibration procedures, work with cross-functional teams on validation tasks.
Seniority
Mid-level, hands-on IC
