Manufacturing Engineer

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. 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 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 Bachelor degree and 1-3 years experience in a similar discipline required. 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. Must have an engineering/technical background. 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. 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 (www.CaringForLife.us) 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 companys global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using Fresenius-kaabi.com which of course includes an extra a in Kabi. Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your drivers license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at Careers@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.