Process Engineering Supervisor

Requirements

• Manufacturing diagnostic testing products/assays
• Sample extraction/testing
• Laboratory experience including Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
• Biochemical processes including enzyme-substrate and antibody interactions
• Advanced data analysis utilizing statistical software such as Minitab
• Experimental design, process analysis and LEAN Six Sigma
• Physical Demands
• Work Environment
• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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Benefits

Additional Information

It's fun to work in a company where people truly believe in what they are doing! This individual will be required to routinely partner with cross-functional teams to lead continuous improvement projects and support the generation and maintenance of process documentation. They will actively participate in equipment and process qualifications and ongoing quality system audits. In addition to direct support responsibility of a manufacturing area, this role will manage several engineers in similar roles within the organization. Job Summary : This individual will be required to routinely partner with cross-functional teams to lead continuous improvement projects and support the generation and maintenance of process documentation. They will actively participate in equipment and process qualifications and ongoing quality system audits. In addition to direct support responsibility of a manufacturing area, this role will manageseveral engineers in similar roles within the organization. Essential Duties and Responsibilities: Assist in updating and generating new Manufacturing, Quality and Maintenance process documentation and data systems. Assist with developing and participating in training for manufacturing and engineering personnel Direct, lead and mentor engineers in direct support of manufacturing activities Revise Standard Operation and Manufacturing Procedures to capture all necessary process, product, and regulatory requirements Assist in developing and managing engineering changes Participates in capital requisition proposals and projects Maintains process maps and value stream maps Assists with complaint investigations and resolution Assists with developing rework protocols where appropriate Participates in maintaining appropriate work environmental conditions and recommends facilities modifications where appropriate Subject Matter Expert on the manufacturing processes and flow Identify and lead manufacturing improvements and cost reduction projects Perform troubleshooting on new and existing process problems Assist with developing and participating in training for manufacturing personnel Revise Standard Operation and Manufacturing Procedures to capture all necessary process, product, and regulatory requirements Lead CAPA related efforts for the technology platform Primary owner for developing and managing engineering changes Participates in capital requisition proposals and projects Maintains process maps and value stream maps Coordinates with Process Support and R&D as a team member for new technology transfer and development of new technology Assists with complaint investigations and resolution Assists with developing rework protocols where appropriate Participates in maintaining appropriate work environmental conditions and recommends facilities modifications where appropriate Other Duties as assigned.

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