Validation Leader
Core
Lead validation activities for new investments and production updates in regulated manufacturing of advanced blood test systems for allergy, asthma, and autoimmune disease diagnosis.
Role type
Validation Leader (Regulated Manufacturing)
Builds
Manufacturing processes and equipment for diagnostic blood test systems
Domain
Medical Devices / Pharmaceuticals / Regulated Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
validation planning, test protocol development, coordination of qualification activities, risk assessment, laboratory analysis, equipment qualification, continuous improvement, cross-functional collaboration
Preferred skills
statistical tools, cleaning validation, computerized system validation, GAMP 5 knowledge, German language proficiency
Technologies
laboratory equipment, embedded software, cleaning processes
Responsibilities
Lead validation activities for new investments and production updates; Develop validation plans, strategies, test protocols, and documentation; Coordinate validation, qualification, and commissioning activities; Participate in URS development and periodic reviews; Perform laboratory analyses and support equipment qualification; Drive continuous improvement initiatives
Seniority
Mid-level, hands-on IC
