Scientist III, Manufacturing Sciences
This job is no longer available
There are still lots of open positions. Let's find the one that's right for you.
About The Position
We are searching for a Upstream Process Engineer 3 with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological input in the development, validation, and transfer of manufacturing processes involving mammalian cell culture. A Process Engineer 3 routinely supports the Process Engineering team as technical owners of customer programs in a manufacturing environment and will be highly involved and act as a subject matter expert in defining and shaping Thermo Fisher Scientific's own technology programs. This role will collaborate internally with supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development and with the client as a Process Engineer program lead. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success. The ideal candidate will collaborate with the process development team to develop standardized methodologies and learn/explore new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification. The candidate will contribute to internal and customer meetings based upon sound evidence guided by minimal direction. They will manage internal projects and tasks, lead client projects, and drive timelines with minimal support from supervision. The candidate will actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures with minimal direction. They will provide scientific expertise for GMP deviations by assessing, reviewing, and approving the impact of major deviations on both the product quality and the validation of the process. In addition, the candidate will lead changes to equipment and process design, proactively and with minimal direction. They will draft, review, and approve Manufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing. The candidate will also draft, review, and approve Process control documents, campaign summary reports, and process validation reports. They will review, analyze, and trend process data without supervision and provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs. The candidate will solve technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility and support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers. Finally, they will provide development and training for Process Engineers/Scientists.
