Sanofi

Chattem was a leading manufacturer and marketer of branded consumer healthcare products, toiletries and dietary supplements, acquired by Sanofi in 2018. The purchase of Chattem allowed Sanofi better access to the U.S. consumer healthcare market while also providing the ability to convert prescription medicines to OTC products.

Process Engineer and Cleaning Validation Intern

August 2018 – May 2019

When applying for my internship, I actually had no idea what being a cleaning validation intern would entail. Working with personal care items (such as Icy Hot, Goldbond, Act Mouthwash, etc.) requires strict protocols due to consumer use. For the duration of my internship, I worked in the R&D branch to create and then validate all cleaning procedures for the machinery used in the manufacturing of newly developed products. Once a chemist had formulated a new product at the bench level, they would then scale up to manufacture a batch at full scale. Next, I would determine the best products, temperatures, soaks, etc. that would be necessary in order to clean all equipment based off of the product formulations. I typically then wrote this into a working SOP to be used while the product was still being formulated. After each cleaning procedure, all equipment would be dissembled and checked thoroughly for any remaining residue to validate the working SOP. This was then written into a formal SOP and validated by my superiors to be used permanently in plant processes. I loved doing this mostly due to the dissembling and reassembling I got to do with the plant equipment. I found it really enjoyable to dissemble massive batch mixers and formulators and all of their joints and metal piping and then to reassemble it again.

Throughout my internship I also spent time going to the packaging plant and two manufacturing facilities to learn more about the processes and to troubleshoot equipment failure. This was typically done by watching the process, noting any differences between the batches at our facility and the one at the full-scale facilities. Many times the issues occurred with uneven heat distribution on larger equipment or incorrect equipment setup.

My day to day activities included weekly DI water testing to ensure no contaminants came into contact with newly manufactured products and safety training implementation. Many of the cleaning validations I created became standard practice so I developed them into training presentations that had to be taken yearly by all plant staff.

 

Job Description

  • Develop protocols and standard operating procedures for product development and cleaning processes

  • Validate new manufacturing and packaging processes

  • Visit all plant sites to ensure all processes are being performed appropriately and troubleshoot equipment failure

  • Conduct weekly DI water testing to ensure unfiltered water does not contaminate industry processes