February 2nd, 2021
The Process Engineer will focus on aspects of introducing a new suite of biopharmaceutical products at our development and manufacturing sites. The majority of processes will be liquid formulations manufactured under a single-use production concept in a cleanroom environment. This role is critical to our clients as this position is involved in onboarding new process equipment, working closely on the ground with production personnel, preparing and executing commissioning, and assisting in qualification protocols. This role will also assist in organizing the production process equipment layout and coordinating with other departments on ensuring the validated status of process equipment.
Provide on the floor support during Manufacturing and Process Development operations for client processes
Evaluate process, materials, and equipment for potential improvements to client processes
Identification of single-use process equipment, raw materials, and consumables of appropriate scale and quality for the GMP execution of client-specified manufacturing processes.
Help to define the execution of the process for GMP manufacturing
Implement equipment, facility, and automation change control, document revisions, and assist or conduct equipment/system/instrumentation failure investigations.
Preparation of protocols and summary reports to support the process equipment and validation program
Maintain engineering drawings and equipment history files.
Bachelors - Engineering
1-3+ years in a cGMP and/or FDA-regulated environment, preferably in the pharmaceutical, biotech, or medical device industry