Project Engineer: Design, Validation & Manufacturing

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

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Medical coverage

Dental coverage

Vision coverage

Wellness program

Job summary

Fresenius Kabi is seeking an engineer to oversee procurement, design and integration of equipment, process systems and utilities. You will lead the project from initial design studies to final validation, and maintain the project schedule and budget while communicating results to all stakeholders.

The role includes a comprehensive benefits package and emphasizes collaboration with manufacturing, quality and regulatory teams.

Responsibilities

• Conducts engineering studies to develop design space for manufacturing construction, process development, equipment procurement and validation master plan.
• Develops and manages site projects with design sketches, layouts, vendor interaction, and specifications.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) with protocols 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 the primary resource for cycle development and optimization on aseptic manufacturing equipment.
• Prepares, writes and executes risk analyses (FMEA, Fishbone) and change requests.
• Prepares funding requests with detailed descriptions, quotes, estimates and schedules.
• Manages installation of equipment and facility modifications, including procurement, startup and budgeting.
• Assists manufacturing and maintenance with problem-solving and cost reduction.

Job description

Fresenius Kabi is seeking an engineer to oversee procurement, design and integration of equipment, process systems and utilities. You will lead the project from initial design studies to final validation, and maintain the project schedule and budget while communicating results to all stakeholders.

The role includes a comprehensive benefits package and emphasizes collaboration with manufacturing, quality and regulatory teams.