Senior Project Engineer – GMP Fit & Finish

Fresenius Kabi USA; Melrose (MA); On-site; USD 100,000 - 115,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical, dental and vision coverage

Life insurance

Wellness program

Job summary

Fresenius Kabi USA is seeking an experienced engineer to lead site projects in a pharmaceutical manufacturing facility. The role focuses on designing, implementing and completing complex engineering initiatives to boost productivity, capacity, and safety.

Ideal candidates have a minimum of 5 years in engineering within pharma, with strong knowledge of FDA regulations and GMP. The company offers a comprehensive benefits package including 401(k), health coverage, and paid time off.

Qualifications

• Bachelor's degree in technical science, engineering, or related field.
• Minimum 5 years of engineering experience in pharmaceutical manufacturing preferred.
• Working knowledge of FDA regulations, GMP, and quality systems preferred.

Responsibilities

• Designs, communicates, implements, and completes complex engineering project plans.
• Ensures projects meet timelines and budgets.
• Evaluates feasibility with detailed time and cost analyses.
• Ensures compliance with state, federal, and local codes including FDA/OSHA requirements.
• Coordinates vendors and manages safety compliance on projects.
• Prepares project specifications, bid packages, and schedules.
• Maintains awareness of pharmaceutical manufacturing needs and standards.
• Reports project status to management and sponsors.

Education

Bachelor's degree in technical science, engineering, or related field

Job description

Fresenius Kabi USA is seeking an experienced engineer to lead site projects in a pharmaceutical manufacturing facility. The role focuses on designing, implementing and completing complex engineering initiatives to boost productivity, capacity, and safety.

Ideal candidates have a minimum of 5 years in engineering within pharma, with strong knowledge of FDA regulations and GMP. The company offers a comprehensive benefits package including 401(k), health coverage, and paid time off.