Job Summary

Responsibilities

The Supervisor, Manufacturing Engineering is responsible for direct supervision of the Manufacturing Engineering team and also serves as the process development expert for the manufacturing operations team at the Melrose Park site. This position has input on the development and oversees the implementation of efficient manufacturing processes, ensuring product quality, and meeting regulatory requirements. This position will provide guidance in the design, development, implementation, and support of all manufacturing lines, equipment, and machinery related to site utilities, production equipment, and facilities. Incumbent is a technical expert within Manufacturing Engineering, and is a resource to the Maintenance and Validation departments to meet all regulatory and company specific policy requirements and to improve plant efficiency, capacity, and capability via continuous improvement and modernization objectives.

Job Responsibilities:

• Supervises a team of Manufacturing Engineers in troubleshooting daily engineering issues on their assigned manufacturing lines serving as the first level of engineering escalation support.
• Provides ideas for continuous improvement initiatives to optimize manufacturing processes, reduce costs, and improve product quality.
• Partners with Sr. Manager, Production to drive improvement projects, including input on funding requests, acquisition, installation, startup, associated documentation, and serve as the communication lead with vendors.
• Rebuilds and upgrades site utility systems and production equipment associated with formulation, filling/capping, lyophilization, packaging, and warehousing/distribution areas as directed by senior leadership.
• Ensures 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.
• Collaborate with cross-functional teams, including Quality Assurance, Supply Chain, and R&D to ensure successful transfer of new products and technologies to manufacturing.
• Lead investigations into deviations, non-conformances, and other manufacturing-related issues, developing and implementing corrective and preventive actions as needed.  
• Mentors junior engineers and train them on different engineering systems to achieve the company goals.  
• Assists in the preparation of funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Job Requirements:

• Must have a Bachelor’s degree in Engineering or related field and 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.

The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.