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 and development 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 carried out in projects, and involve teamwork with experts across functional groups to ensure project success.
What will you do?
· Create detailed Process Flow Diagrams, Standard Operation Procedures, and Job Aids.
· Work with process development to develop standardized methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and depth filtration.
· Contributes to Internal and Customer meetings based upon sound evidence.
· Lead projects with support from supervision as needed.
· Actively drive engineering initiatives to improve practices and procedures
· Provide scientific expertise for GMP deviations.
· Help devise and Implement Corrective and Preventative Actions.
· Lead changes to equipment and processes.
· Draft and own Manufacturing Batch Records ensuring the process is technically accurate and Designed for Manufacturing
· Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs.
· Tackle technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility.
· Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers.
· Provides development and training of Process Engineers/Scientist
How will you get here?
· Bachelor’s degree required in a scientific field, preferably an engineering field.
· 3+ years of experience in GMP regulated Biologics / Pharma Industry
· Follow Environmental Health and Safety policies and procedures and ensure a safe and healthy workplace environment.
· Ability to self-motivate, prioritize work and time
· Demonstrates a foundation in general scientific practices, principles and concepts.
· Writes and communicates effectively.
· Ability to work both independently and as part of a team.
· Knowledge of current Good Manufacturing Practices and US/EU regulations.
· Proficient in Microsoft Word and Excel.
· Ability to stand for long periods of time and gown into manufacturing areas.
This position does not offer relocation benefits.
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