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 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

POSITION SUMMARY Responsible for the installation, maintenance, and modification of all site facilities and utilities. Responsible for repairs, troubleshooting, calibration, and preventative maintenance of associated systems and equipment to include all process utility equipment. Responsible for maintaining good operating condition of equipment used in support of the manu

POSITION SUMMARY Responsible for the installation, maintenance, and modification of all site facilities and utilities. Responsible for repairs, troubleshooting, calibration, and preventative maintenance of associated systems and equipment to include all process utility equipment. Responsible for maintaining good operating condition of equipment used in support of the manu

POSITION SUMMARY The Master Technician provides direct engineering and maintenance support for facility and utility processes and equipment to support the manufacturing of pharmaceutical products in a cGMP compliant manner. He/She will collaborate with multiple site functions to implement new equipment and processes. Responsible for repairs, troubleshooting, calibration,

The Principal Validation Engineer plays a pivotal role as a subject matter expert within Manufacturing Operations, fostering collaboration across quality, regulatory, manufacturing, engineering, and global R&D teams. This individual is entrusted with providing technical support for equipment/system validation and requalification, while actively participating in equipment

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

This position is responsible for ensuring 1) that all import and export transactions are completed within applicable government rules and regulations; and 2) product regulatory compliance is adhered to with the governing regulatory agencies. This position will interface with the following groups (not all inclusive) Regulatory Affairs, freight forwarders, United States Cus