Quality Engineer Validation Specialist

Risk-based validation expertise meets cGMP quality engineering at STEMCELL Technologies in Vancouver, supporting processes, methods, and equipment verification.As a Quality Engineer, you will support lifecycle verification across commissioning, qualification, validation, and project hand-over activities. You will collaborate with Manufacturing, Quality Control, Process Development, and Instrumentation teams. Your work includes risk assessments, protocols, schedules, master plans, and summary reports.Key Responsibilities:
Develop metrics for process effectiveness and improvement progressSupport PPQ conformance lot manufacturing and increased testingPerform non-conformance and CAPA investigations when neededPrepare and coordinate validation, commissioning, and qualification documentationCoach employees on applicable quality standards and proceduresRequirements:
Bachelor’s degree in Biomedical Engineering or equivalentTwo to six years of validation experienceFamiliarity with risk management, ISO 14971, and cGMPExperience qualifying utilities, facilities, equipment, and controlled temperature chambersStrong technical report writing, analysis, project, and time management skillsApply validation, risk management, and technical documentation expertise to quality assurance at STEMCELL Technologies in Vancouver.
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