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Thermo Fisher Scientific Process Engineer 1, Process Validation in St. Louis, Missouri

Job Description

Job Title Process Engineer 1, Process Validation

Requisition ID: 101078BR

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.

Location/Division Specific Information

St. Louis, MO

How will you make an impact?

This person will develop a core competency in process validation and processes 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.

What will you do?

• Assist senior validation members to represent Process Validation on project teams and interface with customer technical and Quality representatives

• Assist with the management of commercialization projects with respect to PV with some oversight

• Write and execute validation protocols and report for processes and unit operations following the requirements of project specific Process Validation Plans, 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 PV, 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

• BS - Chemical or Mechanical Engineering or Statistics. Other engineering or science degree considered based on relevant work experience.

Experience

• 1+ years of Biotech industry experience in commercial scale manufacturing operations preferred

Knowledge, Skills, Abilities

• Strong written and oral communication skills.

• Ability to work both independently and in a team environment, 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 70,000 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.

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

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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