New

Manufacturing Engineer

Fresenius Kabi USA, LLC
$60,966-$85,694 annually
life insurance, 401(k)
United States, New York, Grand Island
3159 Staley Rd (Show on map)
Nov 08, 2025
Job Summary Responsible for engineering project execution by cross functional team of internal and external subject matter experts to improve plant performance, capacity and quality. Under the guidance of the Manager of Engineering or Senior Manufacturing Engineer, the primary responsibility of this position is for design modifications to existing high-speed pharmaceutical manufacturing equipment and tooling in order to improve quality, optimize performance and minimize defects. This position will also be responsible for specifying and procuring new equipment and tooling, managing equipment and facilities projects from conception through completion, including determining and meeting change control requirements. Excellent written and verbal communication skills. Excellent project management skills including experience using MS Project. Experienced AutoCAD or SolidWorks user. Maintain cGMP compliance in accordance with worldwide guidance sources. Salary Range: $60,966-$85,694 annually Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Responsibilities Investigates current equipment performance to identify problems and solutions. Working with operators, quality assurance, and maintenance, identifies and implements necessary improvements. These may include modifications to machine design, tooling, and components. Prepares, writes and executes Risk Analysis (FMEA, Fishbone Diagrams) and Engineering Change Requests. Prepares and executes User Requirement Specifications, Functional Requirement Specifications, Design Specifications/Qualifications, Factory and Site Acceptance Tests, Machinability Studies and Standard Operating Procedures as necessary for new and modified equipment. Prepares funding requests per corporate guidelines, including detailed project descriptions, backgrounds, sketches, alternatives, financial data, justifications, quotations, estimates and schedules. Oversees the installation of equipment and facility modifications. Performs vendor selection, budgeting, procurement of equipment or services, scheduling, vendor coordination, rigging, set-up, training, start-up, and troubleshooting. Prepares and executes validation protocols. Assists Manufacturing and Maintenance with solving problems, improving processes and reducing costs. Maintains compliance with regulatory agency guidance and Fresenius Kabi procedures. Responsible for maintaining automated and controlled systems for manufacturing equipment. Rotating on-call availability for off-shift hours for manufacturing support. Requirements Must have an engineering/technical background. Experience with high-speed manufacturing machinery design and operation preferred. Working knowledge of project management and experience using MS Project preferred. Understanding of plant mechanical and electrical systems, as well as the ability to read construction and process drawings preferred. Must have excellent problem solving and communications skills. Experience with AutoCAD and/or SolidWorks preferred. Computerized and automation control system familiarity strongly preferred. Familiarity with FDA or other regulated industry preferred. Bachelor degree and 1-3 years' experience in a similar discipline required. 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. 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.