Project Engineer: Design, Validation & Equipment Integration

Fresenius Kabi USA, LLC; Wilson (NC); On-site; USD 61,000 - 86,000; Full time

Job summary

Fresenius Kabi USA, LLC in Wilson, NC is seeking a procurement and design engineer to lead the design and integration of equipment, process systems and utilities from initial studies through validation, while maintaining schedule and budget. The role includes cross-functional coordination and comprehensive benefits.

The position involves developing design space, managing site projects, executing validation studies, coordinating with vendors, and ensuring compliance with regulatory expectations.

Responsibilities

• Conducts accurate Engineering Studies to develop design space for manufacturing construction, process development, equipment procurement and validation master plan.
• Develops and manages site projects by leveraging experience, research, design, sketches, layouts, vendor interaction, specs, and discussions with management and site personnel.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) including protocol prep, scheduling, execution, and final report prep; presents results to regulators as needed.
• Develops and maintains Engineering Design and Validation protocols (URS, HDS, SDS, FRS, FAT, SAT, DQ, IQ, OQ, PQ).
• Prepares funding requests with detailed descriptions, backgrounds, sketches, alternatives, financial data, quotations, estimates and schedules.
• Manages installation of equipment and facility modifications; coordinates vendors, procurement, scheduling, rigging, start-up, troubleshooting, and budgeting.
• Assists manufacturing and maintenance with problem-solving, process improvements and cost reduction.

Job description

Fresenius Kabi USA, LLC in Wilson, NC is seeking a procurement and design engineer to lead the design and integration of equipment, process systems and utilities from initial studies through validation, while maintaining schedule and budget. The role includes cross-functional coordination and comprehensive benefits.

The position involves developing design space, managing site projects, executing validation studies, coordinating with vendors, and ensuring compliance with regulatory expectations.