PROJECT ENGINEER

Fresenius Kabi USA•Wilson, NC

5d•$60,966 - $85,694

About The Position

This position is responsible for procurement, design, and integration of equipment, process systems, and corresponding utilities. The Project Engineer leads projects from initial design studies through final validation, maintaining project schedules and budgets and communicating results to stakeholders. The role supports engineering studies, project design and management, validation, equipment cycle development and optimization, risk analysis, funding requests, equipment and facility installations, and manufacturing and maintenance process improvement. Projects may involve aseptic manufacturing equipment and utilities, equipment procurement, and facility modifications.

Responsibilities

Conduct engineering studies to develop the design space used for manufacturing construction, process development, equipment procurement, and validation master plans.
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, computers, and new products, including protocol preparation, scheduling, execution, and final reports; present 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, vendor coordination, rigging, setup, startup, troubleshooting, debugging, training, and budgeting.
Assist Manufacturing and Maintenance with problem solving, process improvement, and cost reduction.