Thermo Fisher Scientific Process Engineer 4 (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 Services 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 functional areas to ensure project success.
The primary responsibilities of a Tech Transfer Engineer 4 are:
This position is a specialized function within the Tech Transfer organization. The incumbent will initially be involved with the design, development of specifications (URS, DRS & FRS), procurement, commissioning (FAT & SAT), method development, and implementation of downstream purification equipment into a new GMP manufacturing suite. This role will then transition into the Tech Transfer responsibilities below, with occasional roles in equipment procurement, optimization, etc.
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 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
Create a Bill of Materials (BOMs) for programs
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 minimal guidance from supervision or senior engineer.
May provide technical mentorship to junior Engineers.
Provide on-floor technical support for manufacturing processing, as needed.
Provide technical support for GMP deviations. Help devise and Implement Corrective Actions.
Bachelor’s degree in scientific field, preferably an engineering field
Hands-on experience with specification development, design, procurement, commissioning, method development, and implementation of GMP equipment.
8-10 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.