POSITION SUMMARY The Documentation Coordinator is responsible for the data processing of Change Notifications (CN) via Documentum, Document Change Requests (DCR), coordination of all controlled document implementation, update of SOP binder sets, control of document archival, and controlled document/logbook issuance, tracking, and reconciliation. The individual in the posi

The Validation Specialist works to support site validation technical experts on specific project teams. The Validation Specialist will participate in the development and execution of test plans for manufacturing equipment and processes, utilities, and facilities. The incumbent will contribute as a key validation representative in support of project team activities and pro

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

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

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,

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 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

POSITION SUMMARY The Master Technician provides direct engineering and maintenance support for processes and equipment used to compound, fill, process, sterilize and finish pharmaceutical products in a cGMP compliant manner. He/She will collaborate with multiple site functions to implement new equipment and processes. The incumbent is a key contributing member to the manu

POSITION SUMMARY The Warehouse Operator Level 2 is responsible for, but not limited to, the accurate picking of orders of material for production and packaging. These orders include tasks generated by production, packaging, and formulation for materials used in commercial and non commercial batches. The wrapping, movement, labelling, and storage of semi finished and finis

Responsible for working in packaging in order to maintain a steady flow of production. This may involve the following loading and unloading tubs and moving pallets. Must follow SOP's and any departmental procedures. Recommends improvements and identifies potential problems which could affect the operation both personnel and equipment related. This position reports to the

Responsible for the full set up and safe, clean, efficient and consistent operation of Inspection and Packaging equipment and all associated documentation. Must be knowledgeable of and able to operate all packaging lines with HMI applications. This position requires extensive amounts of leadership, decision making and coordination of co workers. This position reports to t

Responsible for working in packaging in order to maintain a steady flow of production. This may involve the following loading and unloading tubs and moving pallets. Must follow SOP's and any departmental procedures. Recommends improvements and identifies potential problems which could affect the operation both personnel and equipment related. This position reports to the