The ISO Systems and Sustainability Manager is responsible for the management and maintenance of all the local requirements under ISO 14001 Environmental Management System (EMS), ISO 45001 Occupational Health and Safety Management System (OHSMS), and ISO 50001 Energy Management System (EnMS) for the Plant (Production Unit) in accordance to the current ISO Standards, as wel

The Senior Director, Medical Affairs will provide global medical leadership for the R&D function of the Fresenius Kabi MedTech business, which includes medical devices and solutions associated with transfusion, cell therapies, and infusion technology. Participate in and guide risk management inputs for development projects, support definition and execution of clinical dev

Responsible for visually inspecting filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). The production inspector will work in the Capping Department and on the off line inspection area and therefore must be knowledgeable of procedures and equipment in each area. Responsibilities We offer state

An Associate Scientist is responsible for performing entry level chemical testing to support raw material, in process, stability, and finished products as required for Quality Control. Effectively communicates work and results both orally and in writing. Responsibilities Able to articulate work related issues clearly and effectively to management and peers Perform accurat

The Sr. Manager, Manufacturing Quality US Supply Sites will assure that all activities associated with manufacturing of products within the portfolio of all sites manufacturing for distribution in the US comply with the Manufacturing Quality Assurance concept developed by the Competence Center Manufacturing Quality (CC MQ). The oversight will also extend to the assurance

The Project Manager is responsible for the effective management (organization, financial/project planning, execution, control and evaluation) of all aspects of assigned projects. The Project Manager will effectively collaborate with project governance boards, communicate project status to management and provide resolution of project issues. This position requires a dynami

The Sr. Manager, FDA Compliance (Global Remediation Officer) assures that all plants and I&D Centers having activities with US FDA are in compliance with US FDA regulations, including but not limited to, cGMPs, cGLPs, & cGCPs. This includes foreign facilities within Fresenius Kabi for importation of API or finished products to the US market. This position organizes and pr

The Scientist I is responsible for an intermediate level of expertise in analytical chemistry, chromatographic methods of analysis and instrumentation, including troubleshooting. Independently executes protocols, verifications, method transfers in support of senior level personnel. Directs and provides guidance to associate scientists. Responsibilities Will articulate wor

Responsible for planning and organizing supply replenishment between the Production Unit (PU) and the Market Unit (MU). This position contributes to the execution of the pharmaceutical supply chain goals & objectives. This position relies on experience, judgment, and analysis to insure targeted customer service levels are met. This role is comprised of elements of invento

The Senior Manager, Regulatory Affairs position will support the Regulatory Affairs (RA) Director to help define the regulatory strategy for our innovative next generation technology for cellular therapy. This position will play a substantial role researching regulations, defining and implementing the regulatory strategy and engaging with health authorities to effectively

A Scientist II in Quality control displays an advanced knowledge in chromatographic techniques and instrumentation and guides others in troubleshooting instrumentation and routine test methods. A Scientist II participates in the mentoring and training of less experienced analysts in the group. Responsibilities Performs accurate routing and non routing testing utilizing in

The Technology Transfer Leader is a Manufacturing Operations subject matter expert that will actively collaborate with quality, regulatory, manufacturing, engineering and global I&D teams. The position is responsible for coordinating the transfer and implementation of projects and technology from development groups and customers to the plant manufacturing site. The incumb

This is a 3rd shift role in Melrose Park Responsible for ensuring that the integrated fill line facilities, equipment 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

Experienced Engineering position, leading the software design, coding, documenting, testing and maintenance of real time embedded software and accessory software products. Plans and executes medium sized projects in compliance with standard operating procedure for medical device software development. Designs and implements architecture involving multiple software componen

We currently have an opportunity for a Summer 2024 Chemistry Intern to join the Manufacturing team at our Melrose Park, IL facility. Responsibilities Set up new laboratory system to improve lab workflow to increase productivity Learn and perform QC testing Assist in organizing the lab Assist in any FDA preparation activities Requirements Working toward a Bachelor's degree