Senior Pharma Project Engineer - GMP & Facilities

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

Benefits offered by this job

401k with company contributions

Medical, dental and vision coverage

Paid vacation, holidays and personal '

Employee assistance program

Wellness program

Life insurance

Disability

Job summary

Fresenius Kabi in Melrose Park, IL seeks a site engineer to lead complex manufacturing projects in a GMP environment, focusing on productivity, capacity and safety. You will design, implement and follow up on initiatives to improve processes and equipment efficiency.

You will collaborate with cross-functional teams, manage vendors, ensure regulatory compliance, and deliver projects on time and within budget. A Bachelor's in engineering and 5+ years in pharma manufacturing are preferred.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum 5 years engineering experience; pharmaceutical manufacturing preferred.
• Strong knowledge of FDA regulations and GMP.
• Proficiency with statistical analysis tools.
• Proactive with strong project management and teamwork.
• Able to read construction and process drawings.
• Excellent written and verbal communication and documentation skills.
• Ability to work independently and with cross-functional teams.

Responsibilities

• Execute site engineering projects with design, vendor coordination, and clear specifications.
• Deliver projects on time and within budget.
• Assess feasibility and cost/time for new projects, including BOM.
• Ensure compliance with state, federal, local codes including FDA/OSHA.
• Coordinate vendors and ensure safety and regulatory compliance.
• Prepare bid packages, funding requests, and project documentation.
• Maintain awareness of pharmaceutical manufacturing standards and drive improvements.
• Report project status to managers and sponsors.
• Prepare URS, risk and safety assessments when required.
• Analyze production problems and define project scope.
• Collaborate with multiple functional teams.
• Monitor energy use and propose savings; support ISO 50001.
• Support GMP environment and clean room reviews.
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Systems.

Skills

Project management

Analytical thinking

Interpersonal skills

Communication skills

Attention to detail

Problem solving

Documentation skills

Team collaboration

Education

Bachelor's in engineering or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Project management software

Statistical analysis tools

Job description

Fresenius Kabi in Melrose Park, IL seeks a site engineer to lead complex manufacturing projects in a GMP environment, focusing on productivity, capacity and safety. You will design, implement and follow up on initiatives to improve processes and equipment efficiency.

You will collaborate with cross-functional teams, manage vendors, ensure regulatory compliance, and deliver projects on time and within budget. A Bachelor's in engineering and 5+ years in pharma manufacturing are preferred.