What are the responsibilities and job description for the USA-Process Engineer III (Engineering) position at The Fountain Group?
Currently I have an opening for a Process Engineer located in St. Louis, MO. Details for the position are as follows :
Job Description :
- The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture-based DS Processes within the clients’ biologics manufacturing network.
- We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products.
- The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group.
- This group support commercial operations across a diverse network of manufacturing facilities and external partners.
- Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
- Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
- Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
- Reviews manufacturing processes, deviations, and / or development and production data.
- Reviews manufacturing batch records, protocols, and control strategies.
- Provide technical support and data analysis for investigations and deviation resolution.
- Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
- Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments.
- Bachelors with 5 or masters with 3 years of experience in bioprocess engineering, technology transfer, and downstream or upstream processing. Pharma experience (GMP) required.
Technical Information :
Salary : $70 - $82
