Quality Engineer

General PurposeResponsible for supporting and optimizing manufacturing operations through hands-on engineering oversight of production equipment, utilities, and facility systems within a GMP-regulated environment. This role provides day-to-day engineering support to production operations, ensuring equipment availability, reliability, and performance. Responsibilities include supporting commissioning and qualification activities, coordinating maintenance execution, and ensuring ongoing compliance with GMP requirements. The Production Engineer plays a key role in maintaining safe, efficient, and compliant manufacturing operations through proactive equipment management and continuous improvement.Quality Production Engineering Primary engineering support for manufacturing operations and production equipmentOwner of production equipment performance and reliabilityOwner of equipment maintenance execution and coordinationOversee Equipment Qualification- coordinating contractors, review reports/ approve workSupport process validation and continued process verification activitiesResponsible for Continuous Monitoring program - trend reports, investigation of OOSTeam Member of internal auditing processLead Engineer - perform, conduct, outsource all engineering related projects Job Tasks and ResponsibilitiesEquipment CalibrationManage the tracking and scheduling of equipment calibration. Oversee the calibration management program and coordinate with vendors to ensure timely execution.Validation ManagementPlan, track, and schedule validation activities. Approve and oversee validation protocols, and coordinate scheduling with third-party vendors.Project CoordinationCollaborate with the engineering and quality departments to ensure project deadlines are met and maintain readiness.Continuous MonitoringContinuously monitor, track, report, and maintain systems to ensure optimal performance.Education and ExperienceBachelor's Degree in an engineering discipline Experience with implementation of corrective action programsProduct or industry-specific experienceStrong computer skills including Microsoft Office and databasesKnowledge of tools, concepts and methodologies of QAKnowledge of relevant regulatory requirements

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