PROJECT ENGINEER

301044 Fresenius Kabi USA, LLC; 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

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

• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage

Responsibilities

• 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, and wellness 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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr