Senior Pharma Project Engineer — GMP Facility Leader

Fresenius Group; Melrose Park, Northern (IL, KY); Hybrid; USD 100,000 - 115,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits

Job summary

Fresenius Kabi in Melrose Park, IL seeks an accomplished engineer to design, implement, and complete complex site projects within a GMP environment. You will lead cross-functional efforts, coordinate vendors, and ensure projects meet safety, quality, and regulatory requirements.

The role requires a Bachelor’s in engineering, at least 5 years of engineering experience in pharma manufacturing, and strong knowledge of FDA rules and GMPs.

Qualifications

• Bachelor's in technical science, engineering, or related field.
• Minimum 5 years of engineering experience; pharma manufacturing preferred.
• Excellent knowledge of FDA regulations/guidance and GMPs.
• Preferred knowledge of statistical analysis tools.
• Proactive with strong interpersonal and project-management skills.
• Ability to read construction and process drawings; strong documentation skills.

Responsibilities

• Design, communicate, implement, and complete complex engineering projects in a manufacturing facility.
• Improve productivity, capacity, or safety through analyses and recommendations.
• Coordinate vendor activities and ensure compliance with safety rules and regulations.
• Prepare detailed project documentation: URS, risk & safety assessments, schedules, estimates.
• Monitor project budgets and timelines; report status to management.
• Collaborate with multiple functional teams across site operations.
• Support energy management efforts and GMP-compliant execution.

Skills

Engineering

Project management

Education

Bachelor's degree in engineering or related field

Job description

Fresenius Kabi in Melrose Park, IL seeks an accomplished engineer to design, implement, and complete complex site projects within a GMP environment. You will lead cross-functional efforts, coordinate vendors, and ensure projects meet safety, quality, and regulatory requirements.

The role requires a Bachelor’s in engineering, at least 5 years of engineering experience in pharma manufacturing, and strong knowledge of FDA rules and GMPs.