Quality Engineer

Job Summary Responsible for ensuring that all plant facilities and equipment (critical systems) and associated processes, as well as the quality processes that govern them, are effective, efficient, compliant and remain in a state of control. Responsible for evaluating for compliance and approval of Preventative Maintenance, Metrology, Validation and Qualification activities for all critical systems. Work in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance to solve problems and provide support on compliance issues and corporate quality policy requirements relating to critical systems. 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 Responsible for reviewing weekly system releases. Oversees engineering change controls (ECR) for critical equipment and controlled areas which include preapproval and post approval of change controls. Provides support to the plant during operational run times as well as during maintenance shutdown activities both of which include off shift coverage. Provides quality oversight for software validation, equipment qualification, and facility commissioning and validation. Drafts, and reviews validation documentation for critical systems and equipment. Troubleshoots problems related to critical systems and equipment (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc). Analyzes data and implements both corrective and preventative actions to enhance processes. Analyzes data, conducts root cause investigations, performs gap analyses and risk assessments, develops corrective or preventive actions, and implements procedural and physical changes to reduce defects, improve efficiencies, and ensure compliance with all regulatory requirements, e.g., cGMPs, FDA Guidelines, USP, ISPE, ISO etc. Proactively takes ownership of quality processes and implements solutions in support of continuous improvement. Works with Engineering & Maintenance to identify possible trends in FMS and review impact. Develops, red-lines, reviews, and/or implements quality documents related to critical systems, processes and equipment. Conducts internal audits of all critical systems, processes and equipment, as well as the quality processes that oversee them, and identifies gaps in compliance and opportunities for improvement. Requirements B.S. degree in a technical science is required. Engineering degree is highly preferred. 3 years experience in a highly regulated industry required. 3 years experience in the pharmaceutical industry highly preferred. 3 years experience in change control preferred. Working knowledge of aseptic processing is highly preferred. Working knowledge of cGMP practices to include 21 CFR Part 210, 211 and Part11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines. CQE or CSSGB is a plus. Experience with Trackwise and EDMS preferred. 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.