Thermo Fisher Scientific Process Engineer 2, Downstream Technology Transfer in St. Louis, Missouri
The Downstream Process Engineer is an expert (dependent on level) in his/her field of expertise (downstream processing) and is regarded as such within the Pharma Sciences Group of Thermo Fisher Scientific. The Tech Transfer Engineer provides technological input in the transfer and development of a process and is the technical owner while running customer programs in clinical manufacturing. He/She also contributes to defining and shaping Thermo Fisher Scientific’s own technology programs.
The Process Engineer is part of the Bioprocess Sciences (BPS) organization. This role will work in close collaboration with customers, supervisors and technicians in the Operations department, QA, other Engineers, line management, and scientists in PD. These activities are executed in projects, and involve teamwork with representatives of various to ensure project success.
Working under the guidance and support of supervision or a Senior Engineer, the primary responsibilities of a Tech Transfer Engineer 2 are:
Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include chromatography, utrafiltration, and depth filtration.
Represent Tech Transfer in Internal and Customer meetings and make sound evidence-based contributions.
Document procedures via PFDs, Standard Operation Procedures, and Job Aids.
Draft and own Manufacturing Batch Records ensuring the process is technically accurate and Designed for Manufacturing
Create a Bill of Materials (BOMs) for programs
Generate process flow diagrams (PFDs)
Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs
Implement changes to equipment and processes, with some guidance from supervision or senior engineer.
Department leaders and individual contributors
Other business units
Bachelor’s degree in scientific field, preferably an engineering field
2-5 years of experience in GMP regulated Biologics / Pharma Industry
Other Job Requirements:
Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
Knowledge of engineering principles
Skill set with basic Microsoft office tools (i.e. excel and Word) required
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.