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We are looking for a driven individual to be responsible for process and product engineering in our growing Enzyme Manufacturing Sciences team, based in Madison, Wisconsin.
In this role, you will provide technical and engineering leadership to the Fermentation, Purification, Formulation, and Facilities teams to identify, implement, maintain, scale, and integrate process equipment in an ISO 13485 environment. Additionally, you will partner cross-functionally with Quality and Development teams to help develop processes for new products and improve processes for existing products.
- Partner with Fermentation, Purification, and Formulation teams to develop, design, improve, and qualify test new production schemes and production process equipment to support current and future enzyme demand.
- Work with third-party vendors to identify, design, onboard, and qualify new production equipment, including but not limited to bacterial fermentation, cell lysis, clarification centrifuges, buffer exchange, and chromatography
- Partner with the Facilities team to identify the building utility infrastructure required to support new equipment operations.
- Drive the operational optimization and integration with MES and SCADA solutions for data acquisition and continuous process control.
- Participate in the seamless transfer of new enzyme expression and purification processes from development into manufacturing.
- Assist in troubleshooting production issues related to yield and quality.
- Update and develop Utility and Process Flow Diagrams, equipment and system P&IDs, and User Requirement Specifications for Production Suites.
- Ensure accuracy of Commissioning Protocols, Execution, and Reports for new and/or renovated space.
- Participate in production process Risk Assessments.
- Demonstrate effective communication and stakeholder management with all levels of the organization, across multiple departments and global sites.