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Automation Engineer

Summit Biosciences Inc.

This is a Full-time position in Lexington, KY posted June 9, 2021.

Summit Biosciences is a fast growing leader in the field of Intranasal Pharmaceuticals.

At Summit Biosciences, we aim to provide and promote an environment of continuous learning and improvement, which leads to and harnesses innovation.

We offer fantastic perks & benefits such as strong compensation w/ bonus program, medical/dental/vision/life/disability insurance, 401k + company match, holidays off, PTO, a family like culture, and much more!

The Automation Engineer is responsible for performing and/or leading a wide-array of control systems development, maintenance and engineering activities in a pharmaceutical cGMP environment.

These activities include designing studies, coordinating change management, writing/executing protocols for testing equipment/systems, and summarizing results.

Candidate will also assist in equipment troubleshooting, equipment and facility design, and controls related activities.

This position is also responsible for the development and /or technology transfer of new solutions and modifications to our existing manufacturing process automation systems to solve process problems, optimize equipment performance and reliability.

 Lead projects or participate on project teams to implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products Configure and/or manage site level automation systems (ex: serialization, data historian) Lead the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports Design and execute studies as required to investigate, optimize, troubleshoot, and implement equipment improvements Work on multiple projects simultaneously and coordinate test work with various other departments Lead the development and implementation of automation improvement changes Development of site automation standardization and/or technology master plan.

Champion equipment improvement projects and ensure equipment and systems remain in a qualified state Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services Point person for equipment improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPA’s through participation on cross functional teams Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, execution of automation related PMs (ex: backup/restore) and support of out-of-tolerance investigations related to instrument calibrations Participate in plant engineering, maintenance and calibration activities as needed