Process Engineer

At Millipore Sigma the Process Engineer will work in a dynamic environment supporting the manufacture and testing of high purity filters with a focus on quality, process control/improvements, electro-mechanical assembly, and material handling. The successful candidate will be an enthusiastic team player with high energy and strong engineering skills. This position will support the Pellicon 3 manufacturing operation. Design and upgrade electromechanical equipment to improve reliability and yield.Maintain efficiency and upkeep / upgrade of critical manufacturing equipment.Identify and improve yield loss and scrap opportunities.Develop and recommend new processes and technologies which demonstrate levels of statistical control to achieve cost effectiveness and improved product quality.Establish operating equipment specifications and improve manufacturing techniques.Inspect performance of machinery, equipment, and tools to verify their efficiency and investigate and initiate corrective action of problems and deficiencies to ensure product quality.Develop and/or implement systems improvement projects and supports maintenance and production groups in resolving technical and engineering issues.Provide process on assigned Corrective Action Preventive Action (CAPA).Review capital equipment fabrication activities to ensure manufacturing, construction, installation, and operational testing conform to functional specifications, regulatory safety standards, and user requirements.Develop cost estimates, obtains quotes, and generates capital requests to support new processes and capital equipment purchase.Lead and participate in Equipment and Process Validations activities per Current Good Manufacturing Practices (cGMP) regulations for Medical Device manufacturing.Ensure that product quality features meet product specifications and comply with process validation requirements.Generate, review and approve engineering, manufacturing and quality procedures necessary to support equipment validation/revalidation, launch, and normal production schedules.Facilitate training for individuals involved with the operation and maintenance of processes and equipment introduced to the manufacturing department.Initiate, review/approve change requests, and develops implementation solutions to support operational needs. Who You Are:Minimum Qualifications:Bachelors Degree in Electrical Engineering, Mechanical Engineering, or other Engineering discipline. Preferred Qualifications:1+ year of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or similar regulated industry supporting automated or manual assembly processes.Master's degree in Electrical, Mechanical or Chemical Engineering or related discipline.Instrumentation and PLC experience.Automation and electromechanical knowledge experience.Lean 6 Sigma experience.