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Sanofi Pasteur Co-op 
August 2020 - August 2021

I worked in a cross-functional role to develop and execute protocols for the qualification of sterilization equipment, mainly autoclaves and isolator workstations. I also mentored another intern on sterilization processes and data analysis. 

Ideation

NEED FOR PROJECT

Sanofi Pasteur's Swiftwater site is the largest vaccine plant in the U.S. The sterilization engineering team is always in need of assistance on various qualifications. 

OBJECTIVES

My responsibilities were to develop protocols for and execute qualifications; analyze thermal and biological data using software; synthesize summary reports; and mentor an intern on qualifications and equipment. 

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Process

Problem Identification

Three scenarios necessitated qualifications:

  • Purchase of new sterilization equipment

  • Optimization of existing process

  • CAPAs (corrective and preventative actions) for protocol deviations

Protocol Generation

I wrote protocols for the qualification of sterilization equipment such as autoclaves, isolator workstations, and lyophilizers. I also implemented feedback from other departments, such as quality control and quality validation. 

Keyboard Closeup
Sanitizing Surfaces

Execution

I helped execute almost a dozen qualifications during my co-op. Two executions were led by me- I wrote the protocols, oversaw testing, and created summary reports. 

OUTCOME

Impact

One of the two projects I headed optimized a process which will save an enormous amount of time and money. Other projects' timelines were accelerated because of my assistance. 

Conclusion

Through my co-op, I became proficient with engineering validation concepts and executions. I also gained technical writing skills and experience with cross-departmental dynamics. 

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I was also nominated for co-op of the year by the University of Pittsburgh. 

Contractor

© 2021 by Matt Kart

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