Engineering Tech

3 weeks ago

Durham, United States bioMérieux SA Full time

Description Position Summary: The Engineering Technician is responsible for the support and troubleshooting of bioMérieux manufacturing, formulation, filling, and packaging equipment systems within the site quality management system processes.

Support large and manage small scale Engineering projects at the Durham site.Ensure required Engineering support for the BACT/ALERT manufacturing and packaging lines is available to meet or exceed production targets and product quality. Provide support and oversight to minimize scrap and rework while maximizing overall equipment effectiveness (OEE), cost of finished goods and yield.

Evaluates manufacturing equipment to aid in solving product and process problems. Assist in the implementation and commissioning of new manufacturing equipment, utilize the change management process for modifications as required, and concentrate on continuously improving BACT/ALERT processes.

Primary Responsibilities:

Support Operation of Manufacturing, Formulation, Filling, and Packaging Equipment Troubleshooting and resolution of equipment downtime events. Provide support as a subject matter expert to maintain production equipment in a compliant and fit for intended use state. Conduct Failure Investigations and implement solutions (corrective and preventive actions) that solve equipment mechanical problems, follow-up on corrective and preventive actions to determine their effectiveness and suitability, and prepare written reports on these activities in a timely fashion. Analyze performance data to identify trends to predict potential failures and aid in solving product and process problems. Manage small scale projects Develop immediate and long term MFG continuous improvement plans. Optimize existing manufacturing equipment and processes. Adhere to site procedures to manage service suppliers and contractor work permits during on-site activities. Support large scale projects Participate in commissioning and qualification activities (e.g. SAT, IQ, OQ) and conduct verification activities as required by the change control program. Review and revise Manufacturing and Engineering documents for new and existing manufacturing systems. Provide and document training of technical and production personnel in the application of new manufacturing systems. Education, Skills, & Experience: High School Diploma/GED with a minimum 5 years of technical experience focused on support of manufacturing equipment with mechanical/production level equipment required.

Associate’s degree or higher with a minimum of 3 years of technical experience focused on support of manufacturing equipment with mechanical/production level equipment required.

Minimum of 2 years of experience working in an ISO regulated environment preferred GMP experience preferred

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