Job Description

Lifecore has an opening for a Senior Manufacturing Engineer supporting our aseptic manufacturing activities. The primary responsibility of this position is lead the aseptic engineering activities ensuring timely and effective development, validation, and robust operation of equipment and processes while complying with quality and regulatory requirements. Aseptic engineering activities include capital equipment purchase, implementation and validation, new product development testing and validation, as well as continuous improvement and troubleshooting on existing manufacturing processes.

In this critical engineering role you\'ll have the opportunity to:

• Lead investigations and correct problems involving the manufacturing processes and equipment, which adversely affect the process results
• Identify and implement improvements in the process and related equipment
• Collect and analyze relevant process data to aid in changes which improve the process
• Lead the introduction of new manufacturing processes or changes to existing manufacturing processes with all departments
• Perform the selection and installation of manufacturing/aseptic equipment and systems that will meet the current and future Goals and Objectives of Manufacturing
• Demonstrate in depth understanding of aseptic processing and associated requirements
• Ensure compliance with the Quality System and Design Control requirements

This position could be a great fit for you have strong engineering skills and mechanical aptitude along with the following:

• BS in Engineering (Mechanical or Chemical preferred) or Science
• At least 5 years\' experience in engineering in the medical device/biopharmaceutical or other highly regulated industry
• Experience in project management and process/equipment validation
• In depth understanding of documents, SOP\'s, and technical drawings
• Ability to research, recommend, and specify new equipment and lead a team through the equipment implementation process
• Solid understanding of design control and regulatory requirements for process design and transfer; ability to research, recommend, and specify new equipment

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