PROJECT ENGINEER

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

Job Summary

This position is responsible for procurement, design and integration of equipment, process systems and corresponding utilities. Leads the project from initial design studies to final validation, and maintains project schedule and budget while communicating results to all stakeholders.

Salary Range: $60,966 - $85,694

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Conducts accurate Engineering Studies to develop design space, used for manufacturing construction, process development, equipment procurement and validation master plan.
• Develops and manages site projects by employing past experience, research, design and concept sketches, layouts, drawings, vendor interaction, preparation of specifications, discussions with appropriate management and site personnel.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include 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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.