Senior Process Engineer
Job details
PurposeAn exciting opportunity has arisen for a MS&T Senior Bioprocess Engineer. This position will be part of the MS&T team at our state of the art single-use multi-product commercialisation biotech site.ResponsibilitiesResponsible for the participation in and leading of key technology transfers activities, in support of clinical and commercial new product introduction projects.Development of strategies for and support in the execution of technology transfer, process and clean validation programs in line with company, industry and regulatory standards.Acting as process Subject Matter Expert in the support of process investigations.Use of risk management techniques to assess strategies, prioritize activities and initiatives.Lead other significant business critical projects on site associated with new product introduction and site capability build.Acting as system owner and Subject Matter Expert (SME) to support investigations and using risk management techniques to prioritize activities and initiatives.Ongoing optimization of process equipment and development of future breakthrough business solutions.QualificationsMinimum of 6 years in a biologics drug substance environment.Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.Experience in technology transfers for clinical or commercial biologics strongly desired.Experience with automated systems highly desired.Process validation and cleaning validation experience desired.Minimum of a Bachelor's Level 8 degree in a technical field (e.g. Engineering, Science or equivalent), with experience in the biotechnology or pharmaceutical industry.
#J-18808-Ljbffr Business Engineering & Management
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