Job Summary POSITION SUMMARY The Production Technician II is responsible for supporting operations by training and mentoring Production Operators (Filling and packaging) as well as providing input to the engineering, validation, and maintenance groups at the Wilson site. The Production Technician II serves as a subject matter expert (SME) for a specific process that should be focused on maximizing equipment performance. This individual may support new product introductions and technology transfers to the site. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Serves as a specialist for a specific equipment process in a production area Applies considerable operations knowledge to perform a broad range of tasks on the production floor. Safely operates equipment per procedures and guidelines. Applies judgement in resolving issues and/or making recommendations for various assignments. Trains and mentors new and existing personnel as required. Interfaces with other departments, contractors, and original equipment manufacturers (OEM) to support equipment troubleshooting and perform maintenance. Works with other departments to execute equipment qualification and verification, such as SAT, I/O checkout, and IOPQ, as needed. As equipment SME, provides input into the development of SOPs/documentation related to operations and other cGMP activities. Adheres to cGMP, CFR, and safety requirements to ensure packaging products meet quality standards and production requirements. Performs maintenance PMs on any equipment in the production area where they are SME Performs principal activities of a production operator REQUIREMENTS High School Diploma/GED or equivalent Must have at least five years of experience working in a cGMP-regulated pharmaceutical or medical device setting with at least ten years of total manufacturing experience. Must have effective troubleshooting and problem-solving skills. Demonstrated experience following approved protocols and standard operating procedures (SOPs) and the ability to follow verbal and written instructions. Must be classified as a Qualified Trainer who has successfully trained other operators in the production area. Preferred Skills: Successful completion of continuing education units (CEU) in fundamentals of GMP, pharmaceuticals, Bioworks, or related studies Experience with equipment qualifications (such as conducting FAT, SAT, and IOPQ) and new product introduction technology transfers Experience developing or supporting development of SOPs/documentation related to operations and other cGMP activities 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 match, 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 40,000 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 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 driver’s 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.