Scientist III, Manufacturing Sciences

at  Thermo Fisher Scientific

HOW WILL YOU MAKE AN IMPACT?

We are searching for a Process Engineer with experience in biologics processing. This member of our team provides technological input in the transfer, development, and continuous of a manufacturing process and is the technical owner while running customer programs in clinical manufacturing. They also contribute more broadly to defining and shaping Thermo Fisher Scientific’s own technology programs.
This role will collaborate with customers, supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, line management, and scientists in Process Development. These activities are often carried out in projects, and involve teamwork with experts across functional groups to ensure project success.
This position’s work schedule requires the applicant to work overnight in support of a 24/7 clinical and commercial operations.

• Tackle technical challenges on the manufacturing floor as needed.
• Provide scientific expertise for GMP deviations.
• Create detailed GMP documentation including Process Flow Diagrams, Standard Operation Procedures, and Job Aids.
• Draft and own Manufacturing Batch Records ensuring the process is technically accurate and Designed for Manufacturing
• Work with process development to develop standardized methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, chromatography, ultrafiltration, and depth filtration.
• Actively drive engineering initiatives to improve practices and procedures
• Help devise and Implement Corrective and Preventative Actions.
• Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
• Contributes to Internal and Customer meetings based upon sound evidence.
• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.
• Support changes to equipment and processes.
• Support projects with support from supervision as needed.