Manufacturing Engineering Supervisor – cGMP & Process

Fresenius Kabi USA, LLC

Melrose Park (IL)

On-site

USD 133,000 - 144,000

Full time

5 days ago

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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.