Project Engineer - Design, Validation & Integration

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

Job summary

Fresenius Kabi USA in Wilson, NC seeks an experienced engineer to lead procurement, design and integration of equipment and process systems. You will manage projects from initial studies through final validation, coordinating schedule and budget while communicating results to stakeholders.

Salary range offered is $60,966 to $85,694 with a comprehensive benefits package including health, 401(k) contributions, paid time off and wellness programs.

Qualifications

• Experience in engineering design studies for manufacturing and validation master plans.
• Ability to manage site projects including vendor interaction, specifications, and budgeting.
• Experience executing validation studies and writing related protocols (URS, FRS, IQ/OQ/PQ).

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 with design, layouts, vendor coordination, specifications, and management discussions.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) including protocol prep, scheduling, execution and final reports.
• Develops and maintains Engineering Design and Validation protocols (URS, HDS, SDS, FRS, FAT, SAT, DQ, IQ, OQ, PQ).
• Maintains Process Instructions for manufacturing equipment.
• Acts as primary resource for Cycle Development and Optimization on Aseptic Manufacturing equipment.
• Prepares Risk Analysis (FMEA, Fishbone) and Change Requests.
• Prepares funding requests with project descriptions, schedules and budgets.
• Manages and supervises installation of equipment or facility modifications, including procurement, scheduling and startup.
• Assists Manufacturing and Maintenance with problem solving and cost reduction.

Job description

Fresenius Kabi USA in Wilson, NC seeks an experienced engineer to lead procurement, design and integration of equipment and process systems. You will manage projects from initial studies through final validation, coordinating schedule and budget while communicating results to stakeholders.

Salary range offered is $60,966 to $85,694 with a comprehensive benefits package including health, 401(k) contributions, paid time off and wellness programs.