11 Apr, 2022

Process Engineer II

  • Thermo Fisher Scientific
  • St. Louis, MO, USA
Process Engineer Chemicals

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

 

How will you make an impact?

This growth role is available in Manufacturing Science & Technology’s (MS&T’s) Process Engineering department at Thermo Fisher Scientific’s St. Louis facility.

 

This person will develop a core competency in process engineering from the GMP scale production during late phase clinical runs through PPQ campaigns, and commercial campaigns, as well as identifying and leading technical investigations and providing technical advisement to Manufacturing Technical Support engineers.

 

This role will report to and receive mentorship from a Senior Engineer, Supervisor, or Manager. This role is expected to require a high degree of oversight from supervision, while still being able to self-motivate and work autonomously.

 

What will you do?

  • Assist senior members to represent Process Engineering on project teams and interface with customer technical and Quality representatives
  • Write and execute protocols and report for processes and unit operations following the requirements of project specific to site and company policies, and departmental SOP’s.
  • Compile and perform statistical analysis of manufacturing data,
  • Perform the technical review on other site documents such as deviations, change controls, and batch records.
  • Perform process monitoring (manufacturing data summary and analysis, data presentation), perform activities for lot release (assess deviations and process changes).
  • Make recommendations for process changes and sponsor these changes.
  • Provide data, analyses, write-ups, reviews, and other input to annual product reviews (APR)
  • Actively drive improvements for PE, OPS, and MTS practices and procedures.
  • Assist with CAPA and Deviations with some oversight to achieve quality, timely results.

 

 

How will you get here?

Education

Bachelor’s degree in Chemical or Mechanical Engineering or Statistics required. Other engineering or science degree considered based on relevant work experience.

 

Experience

  • 2+ years of Biotech industry experience in commercial scale manufacturing operations preferred supporting related work as outlined in this role.

 

 

 

 

Knowledge, Skills, Abilities

  • Strong written and oral communication skills.
  • Demonstrates a solid foundation in general scientific practices, principals and concepts
  • Ability to work both independently and in a team environment
  • Ability to self-motivate, prioritize work and time.
  • Proficient in Microsoft Word and Excel.
  • Knowledge of basic statistical analyses such as T-tests, F-tests, box-plots, understanding p values, etc. as well as control charting, Nelson’s/Shewart’s rules (or other statistical trending rules), etc.
  • Basic knowledge of statistical analysis and familiarity with a mainstream statistical software analysis program such as SAS, MiniTab, JMP, or Statistica as well as an intermediate knowledge of process validation principles and their application in biologics drug substance manufacturing.

 

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.


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