• 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