Quality Validation Engineering Specialist

Own validation and qualification programs as a Quality Engineering Specialist in Brantford, Ontario, using risk assessment and statistical sampling expertise.Germiphene Corporation, a Young Innovations company, seeks a Quality Engineering Specialist reporting to the Quality Manager. You will maintain continuous compliance with Health Canada GMP, ISO 13485, and regulatory requirements. The position covers process validation, equipment qualification, calibration, preventive maintenance, and monitored systems. You will coordinate with Production, Packaging, Maintenance, Quality Control, Microbiology, R&D, and Regulatory Affairs.Key Responsibilities:
Develop validation protocols, acceptance criteria, sampling plans, and approved reportsLead process, equipment, cleaning validation, and FMEA risk assessmentsOwn equipment qualification, calibration, and preventive maintenance programsMonitor purified water, temperature, and humidity systemsManage change controls, CAPAs, documentation, training, and auditsRequirements:
Bachelor’s degree in engineering, chemistry, or related physical scienceMinimum five years’ regulated manufacturing quality, validation, or metrology experienceTwo years owning validation, calibration, or preventive maintenance programsExperience authoring protocols, reports, and statistical sampling plansWorking knowledge of Health Canada GMP and ISO 13485Apply quality engineering expertise in validation, qualification, and statistical analysis across Germiphene’s Brantford manufacturing site.
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