Job Summary Salary Range: $80,000 to $110,000 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 Responsible for ensuring that the integrated fill line facilities, equipment, and associated presses, as well as the quality processes that govern them, are affective, efficient, compliant, and remain in state of control. Responsible for evaluating for compliance and approval of Preventative Maintenance, Metrology, Validation, and Qualification activities for the integrated fill line 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 the integrated fill line equipment. Job Responsibilities: Oversees engineering change controls (ECR) for critical equipment and controlled areas related to integrated fill lines 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. Troubleshoots problems related to equipment (water, HVAC, pest control, lyophilizers, vial washers, etc.) Analyzes data and implements both corrective and preventative actions to enhance processes. Analyzes data, supports root cause investigations, performs gap analysis and risk assessments, develops corrective or preventative actions, and implements procedural and physical changes to reduced 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. Addresses daily quality concerns and questions related to operating and environmental concerns. Implements and follows up on corrective actions. Provide in-process QA support to include document review and provide additional support for batch record review and critical processing steps, in order to meet production and release scheduling. Collaborate with cross-functional teams to establish and maintain quality control procedures and documentation. Assures standard operating procedures (SOPs) and batch records define the steps necessary to complete tasks. Writes, reviews, and updates documents as needed. Conducts process audits of all critical processes and equipment, as well as the quality processes that oversee them, and identifies gaps in compliance and opportunities for improvement. Provides training and support to manufacturing personnel on quality standards and procedures. Interacts with regulatory officials to convey the compliance level of the quality system during regulatory inspections. Prioritizes and efficiently completes tasks as assigned by the manager. All employees are responsible for ensuring the compliance to company documents, programs, and activities related to the healthy, safety, environment, energy, and quality management systems, as per their roles and responsibilities. Job Requirements: B.S. degree in a technical science is required. Engineering, Chemistry, or Biology degree is highly preferred. 3 years of experience in a highly regulated industry required, preferably in the pharmaceutical industry. 3 years of experience in change control strongly preferred. Working knowledge of aseptic processing is strongly preferred. Working knowledge of cGMP practices including 21 CFR Part 210, 211, and art 11, Electronic Records, USP, ISO 13485 and 14644, and ISPE trends and guidelines. Experience with Trackwise, SAP, and eDMS preferred. Strong knowledge of relevant software, quality assurance methods, tools and quality manufacturing processes are strongly preferred. Familiar with statistical tools ad techniques for data analysis is strongly preferred. The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment. 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. Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws. 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 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 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.

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