The Automation Engineer will focus on aspects of networking a new suite of equipment at our development and manufacturing sites. This role is critical to designing automation processes and strategies, onboarding new Automation equipment, preparing and executing commissioning, and assisting in qualification protocols. This role will also assist in training, operation, and troubleshooting of the automation systems, transferring of methods and recipes, and driving automation improvements.
Design and evaluate automation architecture, equipment, software and strategies for potential improvements and long-term growth
Write, develop, test, and deploy automation recipes, methods, code updates, and reports
Help to define the automation strategy for Process Development and 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 automation equipment and validation program
Maintain engineering drawings and equipment history files.
Bachelors - Engineering
5+ years in a cGMP and/or FDA-regulated environment, preferably in the pharmaceutical, biotech, or medical device industry