Medical Device Automation Validation Engineer
United Pharma
Support validation of automated and robotic medical-device assembly equipment in Cambridge, Ontario, with strong regulated-manufacturing and data-integrity knowledge.This Senior Automation Validation Engineer validates equipment-based processes, computerized systems, and functional testing activities. You will address part traceability, electronic records, database transactions, system data flows, and regulated-industry controls. Medical-device assembly experience is strongly preferred, alongside protocol execution and automation architecture expertise.Key Responsibilities:
Verify device assembly processes and equipment-based functional testingAssess data-integrity controls against regulated-industry expectationsConfirm part traceability, records, transactions, and system data flowsExecute FAT, SAT, IQ, OQ, and Test Method ValidationCollaborate with suppliers, quality, manufacturing, controls, and stakeholdersRequirements:
Six years working with industrial automation or assembly equipmentExperience in regulated manufacturing environmentsExpertise authoring and executing validation protocolsKnowledge of databases, electronic records, traceability, and data integrityWorking knowledge of sensors, actuators, controls, vision, and roboticsApply validation, traceability, data-integrity, and automation expertise to medical-device manufacturing systems onsite in Cambridge.
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Verify device assembly processes and equipment-based functional testingAssess data-integrity controls against regulated-industry expectationsConfirm part traceability, records, transactions, and system data flowsExecute FAT, SAT, IQ, OQ, and Test Method ValidationCollaborate with suppliers, quality, manufacturing, controls, and stakeholdersRequirements:
Six years working with industrial automation or assembly equipmentExperience in regulated manufacturing environmentsExpertise authoring and executing validation protocolsKnowledge of databases, electronic records, traceability, and data integrityWorking knowledge of sensors, actuators, controls, vision, and roboticsApply validation, traceability, data-integrity, and automation expertise to medical-device manufacturing systems onsite in Cambridge.
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Vacancy posted 1 hour ago
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