Job Summary The Associate Scientist is responsible for collection and testing of routine environmental monitoring samples within aseptic processing fill lines, Isolator fill line, compounding, sterility suite, and component preparation areas for aseptic lines (Building A) and clean rooms areas in new expansion Building B. Collect and test utility samples such as WFI, clean steam and compressed gases. Monitors environmental conditions in laboratory areas during test sessions. Reports testing results and documents in compliance with cGMP and GLP standards. Provides support to Scientist, Lead Scientist, and Supervisor. Prepares media, reagents, sanitizing solutions and equipment for use in testing. Responsibilities The Associate Scientist will perform environmental monitoring in controlled areas for non-viable airborne particulate, viable airborne bioburden, viable surface bioburden, settle plate bioburden and personnel monitoring. Maintain gowning certification and apply good aseptic technique and clean room behavior. Collect and process samples for water for Injection (WFI), clean steam and compressed gases according to established standard operating procedures. Perform bioburden, endotoxin, Total Organic Carbon (TOC), and conductivity testing for utility samples. Perform sub-culturing and Gram-staining of microorganisms. Perform growth promotion on incoming media to release for monitoring use in the facility. Maintain and review temperature records, lab cleaning records, and logbooks. Input results in Laboratory Information Management System (LIMS) database and track microbiological results. Must be able to understand and follow company’s good documentation practices. Compile and submit environmental monitoring data for critical system release. Supports Scientist/ Lead Scientist/ Supervisor with testing and special projects. Carries out special projects independently as required and assigned by supervision. Aids with plant and laboratory equipment re-qualifications as directed. Promptly reports data discrepancies and out of limit conditions to supervision. Carries out documentation, and assist Scientist and Lead Scientist with investigation, incident reports and corrective actions as assigned. Assists in training new departmental personnel in standard operating procedures, training modules and checklists. Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department. Maintains compliance with company policies, training requirements, cGMP’s. Follow safety requirements, maintains good housekeeping of lab areas including 5S. Requirements BS/BA degree in Science or related field. -or- AS/AA degree with 1-3 years of relevant laboratory experience or progressive pharmaceutical lab experience -or- Some college with 5 or more years of relevant laboratory experience or progressive pharmaceutical lab experience. Applicable industries include but are not limited to testing laboratories, food, cosmetic, veterinary, or hospital laboratories. Strong verbal and written communication skills are essential. Attention to detail, people skills and ability to multi-task are essential for success. 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 HRLakeZurich@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.