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Corium International Inc.
Manufacturing Process Engineer
Grand Rapids, MI 49512 United States
Corium International, Inc. is a privately-owned company engaged in the research, development and manufacture of advanced transdermal drug delivery technologies and therapeutic products. We develop and manufacture high-quality products that provide a clear advantage and improve the lives of the people who use them. Corium’s outstanding reputation in development, process development, scale-up and commercial production of complex transdermal products has allowed Corium to become a leading developer and manufacturer in the transdermal pharmaceutical industry, building long-term relationships with top-tier customers.
We are looking for a Manufacturing Process Engineer to work in our Grand Rapids, Michigan facility. This is an exciting opportunity to work for a rapidly growing organization that provides a stimulating environment for professional advancement and to work on projects that are at the leading edge of drug delivery technology.
This position will help lead and implement cost-effective manufacturing process improvements from concept through comissioning in a GMP environment. The candidate will also recommend and implement improvements to production processes, methods, safety, and controls. The Manufacturing Engineer will provide process and product support for manufacturing operations. He/she will use project management, technical knowledge, and problem solving tools and apply those concepts and tools to address problems, implement new processes and products, as well as make continuous improvements in the areas of safety, quality, productivity and cost.
•Lead resolution of technical and process problems, initiate/execute/closure of quality actions for equipment/process modifications.
•Work with the plant support to organize improvement projects. This includes project selection, justification, planning, training, execution, and project reporting.
•Establish and track key performance metrics for achieving continuous improvement goals, SPC, Cpk.
•Member/Lead of project teams for technical transfer or new product scale-up.
•Lead closure of process deviations, investigations, and corrective actions.
•Identify, develop and implement process improvements, equipment improvements/upgrades.
•Coordinate with plant personnel to ensure proper knowledge transfer. This includes best practices sharing and training.
•Identify corrective actions to prevent recurrent deviations. Lead or participate in cross-functional teams to solve production issues.
•Serve as a change agent to challenge existing processes. Use data to communicate and support the opportunities that exist.
•Interface with all supporting functions in plant for the necessary support of the teams.
•Draft and revise SOPs and Batch Records for commercial processes.
•Conduct relevant process, cGMP and safety training.
•Depending on background and formal training, manage advanced lean/six sigma projects in plant, including project management and supervision. Must be able to act quickly to lead, develop, and implement solutions in cooperation with plant improvement teams.
•Document processes using written work instructions.
•Effectively manage specific project deliverables, on time and within budget.
•Problem analysis and problem resolution.
•Provide technical assistance to production floor.
•Maintain a working knowledge of GMP/FDA requirements
Education, training, experience:
•Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Packaging, or related field.
•3 years or more experience in a pharmaceutical and/or consumer goods manufacturing environment developing and implementing new processes, equipment, and technology is preferred, but will train a motivated new graduate.
•Specialization and expertise in the areas of adhesive systems, mixing operations, coating operations, extrusion operations, converting operations, and/or packaging is helpful.
•Previous GMP/FDA experience helpful.
•Must be a motivated, result-orientated individual.
•Problem analysis and problem resolution.
•Excellent interpersonal, communication, and presentation skills.
•Excellent technical writing skills.
•Strong team player.
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