Manufacturing Engineering Supervisor – cGMP & Process

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 133,000 - 144,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) with company matching

Wellness program

Job summary

Fresenius Kabi USA, LLC seeks a manufacturing engineering leader to supervise a team, drive continuous improvements, and manage complex projects across formulating, filling, lyophilization, packaging, and warehousing lines. You will coordinate with QA, Supply Chain, and R&D to transfer new products to manufacturing and ensure strict cGMP compliance.

The role emphasizes equipment upgrades, system validation, and strong analytical problem-solving to minimize downtime and boost product quality.

Qualifications

• Bachelor's degree in Engineering and five years in plant manufacturing within a regulated cGMP environment.
• Experience monitoring performance and troubleshooting mechanical and HMI interfaces.
• Experience managing improvement projects and troubleshooting equipment with industrial automation systems.
• Experience reading P&IDs, wiring diagrams, and architectural drawings.
• Experience ensuring work complies with cGMP, FDA regs and pharma standards.
• Experience analytical troubleshooting and root cause analysis for permanent solutions.
• Experience with Siemens or Allen-Bradley control systems and PLC programming.
• Experience coordinating and directing contractors on site projects.

Responsibilities

• Supervise a team of Manufacturing Engineers in troubleshooting daily engineering issues on assigned lines (first level escalation).
• Provide ideas for continuous improvement initiatives to optimize processes, reduce costs, and improve product quality.
• Drive improvement projects including funding inputs and vendor communication with Sr. Manager, Production.
• Rebuild and upgrade site utilities and equipment across formulation, filling, lyophilization, packaging and warehousing areas.
• Ensure equipment and systems are validated and compliant with cGMP, OSHA, EPA, ISO and local regs.
• Support successful transfer of new products to manufacturing with cross-functional teams.
• Lead investigations into deviations and CAPAs.
• Mentor junior engineers and train on engineering systems.

Skills

Engineering leadership

Troubleshooting

Root cause analysis

Cross-functional collaboration

Project coordination

Education

Bachelor's degree in Engineering

Tools

Siemens PLC

Allen-Bradley PLC

Industrial automation systems

Job description

Fresenius Kabi USA, LLC seeks a manufacturing engineering leader to supervise a team, drive continuous improvements, and manage complex projects across formulating, filling, lyophilization, packaging, and warehousing lines. You will coordinate with QA, Supply Chain, and R&D to transfer new products to manufacturing and ensure strict cGMP compliance.

The role emphasizes equipment upgrades, system validation, and strong analytical problem-solving to minimize downtime and boost product quality.