Senior Project Engineer — PVC-Free IV Bag Manufacturing

Fresenius; Wilson (NC); Hybrid; USD 132,000 - 133,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Wilson, NC seeks an experienced engineer to drive projects around its freeflex PVC-free IV bag technology. You will coordinate site operations, engineering, and QA to implement new processes and equipment, ensuring high product quality and yield.

The role requires a Bachelor’s degree in engineering and 5+ years in validated manufacturing, with hands-on experience in cGMP environments and equipment qualification for terminally sterilized products.

Qualifications

• Bachelor's degree in engineering and 5+ years in validated manufacturing of terminal sterilized pharmaceuticals.
• Experience with PVC-free IV bag material technology and cGMP environments.
• Experience qualifying processes, equipment, and systems including terminal sterilization and product integrity.
• Collaborating with QA, QC, engineering, operations to implement and train on new tech.
• Interpreting production data, identifying deviations, and applying problem-solving methods.

Responsibilities

• Manage implementation of projects related to the manufacturing of PVC-free IV bags with freeflex bag technology.
• Involve site operations, facility and engineering teams in learning new technology systems.
• Oversee installation of equipment, procure services, coordinate suppliers, scheduling and budgeting.
• Develop site projects using design sketches, supplier interaction, specifications, and management discussions.
• Analyze process sequences and production issues to improve quality and yield.
• Prepare process troubleshooting, training and knowledge management documents.
• Conduct risk assessments, validation activities, and support continuous improvement initiatives.
• Interface with QA, QC, and Engineering Services to ensure equipment availability and process stability.

Skills

Project management

Process improvement

Root cause analysis

Cross-functional collaboration

Data interpretation

Education

Bachelor's degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or Process Engineering

Job description

Fresenius Kabi in Wilson, NC seeks an experienced engineer to drive projects around its freeflex PVC-free IV bag technology. You will coordinate site operations, engineering, and QA to implement new processes and equipment, ensuring high product quality and yield.

The role requires a Bachelor’s degree in engineering and 5+ years in validated manufacturing, with hands-on experience in cGMP environments and equipment qualification for terminally sterilized products.