Project Engineer

Fresenius Kabi•Wilson, NC

About The Position

This position is responsible for procuring, designing, and integrating equipment, process systems, and associated utilities. The Project Engineer leads projects from initial design studies through final validation, maintains project schedules and budgets, and communicates results to stakeholders. The role supports manufacturing construction, process development, equipment procurement, and validation planning, and serves as a primary resource for cycle development and optimization on aseptic manufacturing equipment. The position also manages equipment and facility installations or modifications, including vendor selection and coordination, procurement, scheduling, setup, startup, troubleshooting, training, and budgeting. It assists Manufacturing and Maintenance in resolving problems, improving processes, and reducing costs.

Responsibilities

Conduct engineering studies to develop design space for manufacturing construction, process development, equipment procurement, and validation master planning.
Develop and manage site projects using research, design concepts, sketches, layouts, drawings, vendor interaction, specifications, and discussions with management and site personnel.
Execute validation studies for utilities, equipment, cleaning, processes, computer systems, and new products, including protocol preparation, scheduling, execution, and final reports.
Present validation results to regulatory agencies when necessary.
Develop and execute engineering design and validation protocols, including URS, HDS, SDS, FRS, FAT, SAT, DQ, IQ, OQ, and PQ.
Develop and maintain process instructions for manufacturing equipment.
Serve as the primary resource for cycle development and optimization on aseptic manufacturing equipment, including sterilizers, lyophilizers, automated decontamination systems, parts washers, CIP/SIP, formulation, filling, depyrogenation, inspection, and packaging equipment.
Prepare, write, and execute risk analyses, including FMEA and fishbone diagrams, and critical change requests.
Prepare funding requests according to corporate guidelines, including project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates, and schedules.
Manage and supervise equipment installation and facility modifications or additions, including vendor selection, procurement, scheduling, coordination, rigging, setup, startup, troubleshooting, debugging, training, and budgeting.
Assist Manufacturing and Maintenance with problem solving, process improvement, and cost reduction.
Maintain project schedules and budgets and communicate results to stakeholders.