Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How will you make an impact?  

We are searching for a Upstream Process Engineer 3 with education and experience in biopharmaceutical processing or a related field. This member of our team provides technological input in the development, validation, and transfer of manufacturing processes involving mammalian cell culture. A Process Engineer 3 routinely supports the Process Engineering team as technical owners of customer programs in a manufacturing environment and will be highly involved and act as a subject matter expert in defining and shaping Thermo Fisher Scientific’s own technology programs. This role will collaborate internally with supervisors and technicians in the Operations department, Quality Assurance, fellow Engineers, and scientists in Process Development and with the client as a Process Engineer program lead. These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success. 

Standard Job Duties

• Collaborate with the process development to develop standardized methodologies and learn/explore new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification. 

• Contribute to Internal and Customer meetings based upon sound evidence guided by minimal direction. 

• Manages internal projects and tasks, leadclient projects, and drive timelines with minimal support from supervision. 

• Actively identify error proofing opportunities and initiate and drive engineering initiatives to improve practices and procedures with minimal direction. 

• Provide scientific expertise for GMP deviations by assessing, reviewing and approving the impact of major deviations on both the product quality and the validation of the process. 

• Lead changes to equipment and process design, proactively and with minimal direction. 

• Draft, review and approveManufacturing Batch Records, Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods,and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing.

• Draft, review, and approveProcess control documents, campaign summary report and process validation reports

• Reviews, analyzes and trends process data without supervision

• Provide technical feedback on documents created by other departments, such as Tech Transfer Protocols and SOPs. 

• Solve technical challenges on the manufacturing floor as needed for a 24/7 manufacturing facility. 

• Support our MSAT team with additional tasks to improve the site, ensure patient safety, and deliver for our customers. 

• Provides development and training forProcess Engineers/Scientists.

Ideal candidate background

Education * *

• Bachelor’s degree required in a scientific field, preferably an engineering field.  Master's degree and Ph.D. also considered.

Experience * *

• 5+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience (or master's degree + 3 years' experience or Ph.D.).

• 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, principles, 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.

• Mammalian Cell Culture experience, bioreactor experience, or pharmaceutical data analusis is a plus. 

• Proficient in Microsoft Word and Excel. 

• Ability to stand for prolonged periods of time and gown into manufacturing areas. 

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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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. 

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.