The Downstream Process Engineer is an expert (dependent on level) in his/her field of expertise (downstream processing) and is regarded as such within Thermo Fisher Scientific. The Process 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.
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.
The primary responsibilities of a Process Engineer 2 are:
- Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include chromatography, ultrafiltration, and depth filtration.
- Represent Process Engineering in Internal and Customer meetings and make sound evidence-based contributions.
- Manage projects with supervisor oversight
- Actively drive engineering initiatives to improve practices and procedures
- Provide technical support for GMP deviations. Help devise and Implement Corrective Actions.
- Implement changes to equipment and processes
- 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
- Review and provide technical oversight on documents created by other departments, such as Tech Transfer Protocols and SOPs
- Provide on-floor technical support for manufacturing processing, as needed.
- Department leaders and individual contributors
- Project leads
- Other business units
- Bachelor’s degree in scientific field, preferably an engineering field
- 4+ years of experience in GMP regulated Biologics / Pharma Industry
Other Job Requirements:
- Adhere to 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 solid foundation in general scientific practices, principals and concepts
- Strong written and oral communication skills.
- Ability to work both independently and in a team environment
- Knowledge of current Good Manufacturing Practices and US/EU regulations.
- Proficient in Microsoft Word and Excel.
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.