Regulated Manufacturing Validation Specialist

Lead regulated manufacturing validation in Brantford, Ontario, with responsibility for equipment qualification, CAPAs, and continuous compliance programs.As Quality Engineering Specialist at Germiphene Corporation, part of Young Innovations, you will report to the Quality Manager. Your work will support dental pharmaceutical, natural health, and medical device products. You will determine technical approaches, direct floor execution, interpret data, and finalize reports. The position requires coordination across Production, Packaging, Maintenance, Quality Control, Microbiology, R&D, and Regulatory Affairs. You will also present program information during internal, customer, and regulatory audits.Key Responsibilities:
Evaluate processes and establish critical parameters under the Validation Master PlanDirect IQ, OQ, and PQ for production and laboratory equipmentInvestigate out-of-tolerance results and control equipment statusDrive assigned change controls and CAPAs through documented closurePresent validation and equipment programs during auditsRequirements:
Five years’ minimum experience in regulated manufacturing quality, validation, or metrologyBachelor’s degree in engineering, chemistry, or related physical scienceIndependent process, equipment, and cleaning validation protocol experienceComputerized calibration and maintenance management system administration experienceUnderstanding of metrology, data integrity, and computerized system requirementsBring independent technical judgment and regulated manufacturing experience to validation, equipment control, investigations, and CAPA ownership.
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