The Associate Director, Validation is accountable for validation activities at the KBI Boulder facility for the following disciplines Facilities qualification Utilities qualification Equipment qualification GAMP 3 5 automation qualification including Part 11 Cleaning validation including changeover equipment strategies Steaming validation Air visualization validation Prod

Required to have close visual acuity (e.g. preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small parts) and depth perception (with or without glasses/contacts) Required utilization of provided personal protection equipment (PPE) Occasional exposure to potential hazards such as hot water, s

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 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

This Manufacturing Sciences and Technology (MS&T) Principal Engineer position will lead a team responsible for process development, and process transfer for clinical and commercial manufacturing. This person and their team will also have responsibilities for the ownership of processing equipment and unit operations, including system design, procurement, installation, and

Histology Technician II Location Location US CO Fort Collins ID 2024 4594 Category Operations Type Full Time Permanent Overview The Histology Technician will be responsible for performing histology tasks for nonclinical studies, including tissue trimming, processing, embedding, sectioning, staining, and slide quality control assessment. The histology laboratory performs p