Job Description

How will you make an impact?

The Downstream Process Engineer is an expert (dependent on level) in the 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 and commercial manufacturing. The candidate will also contribute 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 specialists, line management, and scientists in PD. These activities are executed in projects, and involve teamwork with representatives of various to ensure project success.

What will you do?

• Work with process development to define common methodologies for conducting unit operations at the manufacturing scale. Typical manufacturing operations include chromatography, ultrafiltration, viral filtration and viral inactivation.
• Represent Process Engineering in Internal and Customer meetings and make sound evidence-based contributions.
• Run projects with supervisor/senior 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 guidance on documents created by other departments, such as Tech Transfer Protocols and SOPs
• Provide on-floor technical support for manufacturing processing on a rotation basis, as needed.

How will you get here?

Education

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

Experience

• 2+ years of experience with a Bachelors degree, or 1+ years experience with a Master’s degree. Experience preferred 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, principals 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 periods of time and gown into manufacturing areas.

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, tackle 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.

Accessibility/Disability Access

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