Shift: 7 pm to 5 am

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The St Louis site is a fast-paced, 24/7 biologic drug substance manufacturing facility with approximately 800 employees, by year-end, we will be closer to 1k due to a site expansion project going on now. Overall, this GMP facility is focused on cell process development to support the clinical phase and commercial manufacturing by producing products to treat a variety of chronic health conditions including cancers and other life-threatening diseases, as well as COVID-19.

Discover Impactful Work:

The Downstream Process Engineer is a guide in biologics 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. The Downstream Process Engineer also assists in 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, process validation, other Engineers, line management, and scientists in PD. These activities are performed in projects, and involve teamwork with representatives of various to ensure project success.

A day in the Life:

• Assist team lead to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include chromatography, ultrafiltration, and depth filtration.
• Assist team lead in Internal and Customer meetings and make sound evidence-based contributions.
• 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 guidance on documents created by other departments, such as Tech Transfer Protocols and SOPs
• Provide on-floor technical support for manufacturing processing, as needed.
• Assist Process Validation needs during validation studies.

Keys to Success:

Education

• Bachelor’s degree required in a scientific field, preferably an engineering field.

Experience

• 0-2+ years of experience in GMP regulated Biologics / Pharma Industry

Knowledge, Skills, Abilities

• 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.

Relocation Benefits

This position does not offer relocation benefits

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

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