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 Technical Product Engineer provides technical service support, training, and communications to global/regional field service teams and manufacturing for infusion pump technology. The Technical Product Manager provides serviceability input and service planning for R&D product updates and new product development. This position is a member of a team dedicated to total in

POSITION SUMMARY The Technical Writer is responsible for independently investigating and reporting on deviations to the manufacturing process, customer complaints on finished product, and other manufacturing problems as assigned. Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT Responsible for describing problems, identifying possible causes, collecting an

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 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

Aseptic Control Operators are responsible for the cleaning, changeover, setup, startup, operation, and breakdown of production lines. Additionally, they may be assigned tasks related to the general upkeep of the area, such as unloading ovens and sterilizers, performing routine cleaning, and performing minor maintenance. All of these activities are governed by strict proce

The ISO Systems & Sustainability Manager is responsible for the management and maintenance of all local requirements under the 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 with the current ISO Standards, as we

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 Training Specialist is responsible for the successful design, development and implementation of training at the Plant Level. Work closely with the Training Manager in developing and implementing training plans. Design needs/tasks analysis, develops training materials, implements project plans for appropriate locations, schedules training sessions, writes training modu

We currently have an opportunity for a summer 2024 intern to join the Engineering team at our Grand Island, NY facility. Responsibilities Interact with Production and Engineering personnel to identify areas of improvement Support engineering team with project execution Help with engineering and manufacturing documentation Provide engineering support related to capital pro

The Senior Principal Engineer, Infusion Systems, is a Systems Engineer with expertise managing product risk documentation for medical device products and collaborating with the broader R&D team to develop robust records for the Design History File. The engineer has responsibility for risk assessments and documentation for the Ivenix Infusion System during the product deve

The Full Stack Senior Software Engineer will enhance our web application user interfaces, services and data model while working closely with platform engineers. You will be influential in maintaining the current product as well as influencing and developing the next generation of the product. In addition, you will contribute to the overall design and development of other

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