11 Jan, 2021

Process Engineer

  • Thermo Fisher Scientific
  • Millersburg, PA, USA
Process Engineer   Biochemicals / Pharmaceuticals

Job Description

When you are part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. We have approximately 65,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications

 

Position Summary

This position serves as a key scientific and technical process engineering resource at the Millersburg, PA manufacturing facility. This will include partnering with manufacturing to meet the production schedule, demonstrating excellence in validation engineering, and driving toward process control and process discipline.

 

Essential Functions

 

Follow all safety and cGMP requirements

Create and execute validation packages with emphasis on statistical rigor

Use design of experiments to ensure processes are validated

Create and execute Installation Qualifications, Operational Qualifications, Process Challenges and Performance Qualifications for the facility

Perform trending and monitoring of critical quality attributes, critical process parameters to maintain product quality and control process drift

Participate on project teams to start-up new facilities, equipment or processes

Document changes and improvements through the Quality Management System

Execute laboratory studies and write technical reports summarizing laboratory results

Participates on technical teams for deviation investigation resolution, equipment or process validation activities, training on new process technologies and on significant changes to manufacturing procedures

Proposes process improvement opportunities and /or corrective actions to increase yield, maximize production capacity, reduce product costs and decrease process variability while maintaining regulatory compliance

Off hours work may be required


Skills and Abilities

  • Excellent technical aptitude
  • Champion of data driven decisions and process control/process discipline
  • Effective communication skills both written and verbal
  • Ability to work independently and as a member of a cross-functional team
  • Strong willingness to learn, be mentored, and improve self, and train others
  • Ability to work in fast-paced results orientated environment
  • Experience with validation engineering in a regulated environment
  • Desire to contribute to the business and its team
  • Highly organized and self-motivated
  • Ability to effectively solve complex technical problems
  • Ability to remain calm and effectively resolve potentially harmful/stressful situations
  • Very hands-on work ethic
  • Ability to work flexible hours if needed

 

Minimum Qualifications/ Requirements

  • Bachelor’s degree in Engineering, Science, Technical or related field
  • Minimum of 2 years of experience in a manufacturing environment

 

Additional Qualifications (Plus)

  • Prior experience in validation engineering
  • Mechanical engineering skills (Solidworks, Auto Cad, etc.)
  • Experience working in a cGMP manufacturing setting
  • Project Management/Project Leadership
  • Six-Sigma Certification

 

 

At Thermo Fisher Scientific, each one of our 55,000 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.


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