Supervisor, Manufacturing Engineers

Fresenius Kabi USA•Melrose Park, IL

3d•$132,922 - $144,117•Onsite

About The Position

This role supervises a team of Manufacturing Engineers, providing first-level engineering escalation support for daily issues on assigned manufacturing lines. The position focuses on driving continuous improvement initiatives to optimize processes, reduce costs, and enhance product quality. Key responsibilities include managing improvement projects from conception to completion, overseeing the rebuild and upgrade of site utility systems and production equipment, and ensuring the validated state of equipment and systems in compliance with cGMP, OSHA, DEC, EPA, ISO, and local regulations. The role also involves leading new product and technology transfers, investigating deviations, mentoring junior engineers, and assisting with funding requests. Compliance with Health, Safety, Environment, Energy, and Quality Management Systems is also a critical aspect of this position.

Requirements

Bachelor’s degree in Engineering or related field
Five (5) years of experience in plant manufacturing within a regulated cGMP environment
Experience monitoring performance and performing troubleshooting of mechanical and HMI equipment interfaces
Experience managing improvement projects and troubleshooting manufacturing equipment utilizing industrial automation systems, including computerized and automated machinery, plant mechanical and electrical systems
Experience reading process and instrumentations drawings (P&IDs), wiring diagrams, architectural and construction drawings
Experience ensuring work is performed in accordance with regulated pharmaceutical standards for process and documentation, including cGMP, FDA regulations, and industry standards related to pharmaceutical manufacturing
Experience performing analytical troubleshooting and root cause analysis to identify and resolve underlying issues, ensuring permanent solutions and minimizing equipment downtime
Experience working with Siemens or Allen Bradley control systems and PLC programming of highly automated manufacturing equipment
Experience coordinating and directing contractors and/or team members in site projects

Responsibilities

Supervise a team of Manufacturing Engineers in troubleshooting daily engineering issues on assigned manufacturing lines serving as the first level of engineering escalation support (20%).
Provide ideas for continuous improvement initiatives to optimize manufacturing processes, reduce costs, and improve product quality (15%).
Drive improvement projects, including input on funding requests, acquisition, installation, startup, associated documentation, and serve as the communication lead with vendors by partnering with Sr. Manager, Production (15%).
Rebuild and upgrade site utility systems and production equipment associated with formulation, filling/capping, lyophilization, packaging, and warehousing/distribution areas as directed by senior leadership (10%).
Ensure the validated state of equipment and systems and compliance with all applicable cGMP (including data integrity), OSHA, DEC, EPA, ISO, and local government regulations on assigned lines (10%).
Ensure successful transfer of new products and technologies to manufacturing by collaborating with cross-functional teams, including Quality Assurance, Supply Chain, and R&D (8%).
Lead investigations into deviations, non-conformances, and other manufacturing-related issues, developing and implementing corrective and preventive actions (5%).
Mentor junior engineers and train them on different engineering systems to achieve the company goals (10%).
Assist in the preparation of funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates, and schedules (5%).
Ensure compliance with company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems (2%).