Job Summary

Responsibilities

Duties: 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%).

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. Position requires: 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.

Salary: $132,921.60 to $144,117.41 per year

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.