Scientist II, Manufacturing Sciences

We are searching for a Process Engineer II 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.

A person in this role routinely supports the PE team as technical owners of customer programs in a manufacturing environment and will assist 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 occasionally with the client.

These activities are conducted in projects and involve teamwork with experts across functional groups to ensure project success.

Standard Job Duties

• Draft Standard Operation Procedures, and Job Aids.
• Collaborate with the process development to assess standardized methodologies and learn new methodologies for conducting unit operations at the manufacturing scale including cell culture, harvest, and purification.
• Support Internal and Customer meetings based upon sound evidence guided by supervision.
• Manage internal projects and tasks and assists in leading client projects and managing timelines with support from supervision.
• Actively identify error proofing opportunities and drive engineering initiatives to improve practices and procedures with supervision.
• Provide scientific expertise for GMP deviations by assessing the impact of major deviations on both the product quality and the validation of the process.
• Lead changes to equipment and process design.
• Draft, review and approve Manufacturing 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 Process control documents, campaign summary report and process validation reports
• Reviews, analyzes and trends process data with minimal direction
• 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 for Process Engineers / Scientists.

How will you get here?

Education

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

Experience

• 2+ years of experience in GMP regulated Biologics / Pharma Industry, or equivalent experience.
• Follow Environmental, Health and Safety policies and procedures and ensure a safe and balanced workplace environment.
• Ability to self-motivate, prioritize work and time.
• Demonstrates a foundation in general scientific practices, principles, and concepts.
• Writes and communicates efficiently.
• Ability to work both independently and as part of a team.
• Knowledge of current Good Manufacturing Practices and US / EU regulations.
• Novice knowledge of statistical methods used for Pharmaceutical Process Analysis 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.

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