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

The Vice President, Medical Affairs is responsible for leading the development and execution of strategic and tactical plans for Headquarter (HQ) and Field medical affairs teams pre launch, launch, and post approval for biosimilars and biologic products. This leader is an active and collaborative member of the Biosimilar Leadership Team (BLT). Leads local and collaborates

1. Create excel spreadsheet to support Nitrosamine Risk Assessment for all US products 2.Data collection from various sources, such as SAP, Documentum/eDMS, Regulatory database, external manufacturer documentation 3.Needs to collaborate with various functions within the organization Compensation $20.50/hr $24.50/hr depending on level of education Responsibilities Student

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 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

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 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 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

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 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