Project Engineer - Process Design, Validation & Procurement

Fresenius Kabi USA; North Carolina; 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

Employee assistance program

Health benefits (medical, dental, and

Job summary

Fresenius Kabi USA is seeking a procurement and engineering professional to lead the design, integration, and validation of complex manufacturing equipment and process systems in North Carolina. You will manage projects from initial studies through final validation, while controlling schedules and budgets and communicating results to stakeholders.

The role involves coordinating with cross-functional teams, performing comprehensive validation, and developing risk analyses to support manufacturing

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 applying experience, research, design and concept sketches, layouts, drawings, vendor interaction, preparation of specifications, discussions with management and site personnel.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) including protocol preparation, scheduling, protocol execution, and final report preparation.
• Presents results to Regulatory Agency when necessary.
• Develops and executes Engineering Design and Validation protocols (URS, HDS, SDS, FRS, FAT, SAT, DQ, IQ, OQ, PQ).
• Develops and maintains Process Instructions for manufacturing equipment.
• Acts as the primary resource for Cycle Development and Optimization on Aseptic Manufacturing equipment (Sterilizers, Lyophilizes, Automated Decontamination, Parts Washer, CIP/SIP, Formulation, Filling, Depyrogenation, Inspection, Packaging).
• Prepares, writes and executes Risk Analysis (FMEA, Fishbone Diagrams) and Critical Change Requests.
• Prepares funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules.
• Manages and supervises the installation of equipment and/or facility modifications or additions.
• Includes vendor selection, procurement of equipment or services, scheduling, vendor coordination, rigging, set‑up, start‑up, troubleshooting, de‑bugging, training and budgeting.
• Assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs.

Job description

Fresenius Kabi USA is seeking a procurement and engineering professional to lead the design, integration, and validation of complex manufacturing equipment and process systems in North Carolina. You will manage projects from initial studies through final validation, while controlling schedules and budgets and communicating results to stakeholders.

The role involves coordinating with cross-functional teams, performing comprehensive validation, and developing risk analyses to support manufacturing