What are the responsibilities and job description for the Automation Tech position at Summit Biosciences Inc.?
The Automation Technician is responsible for performing and/or leading a wide-array of manufacturing equipment maintenance and engineering activities in a pharmaceutical cGMP environment. These activities include designing studies, writing and executing change management and protocols for testing equipment, and summarizing results. Also assists in equipment troubleshooting, equipment and facility design, and controls related activities.
Essential Duties:
- Participate on project teams to implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products
- Assist in the design and procurement of new process and utility equipment.
- Assist in the 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
- Participate in the development and implementation of automation improvement changes
- Champion equipment improvement projects and ensure equipment and systems remain in a qualified state
- 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
- Other duties as assigned
Qualifications
- AS/BS in engineering or related life science
- Previous work experience in a related field
- Ability to maintain focus on tasks until completion and think analytically to solve problems
- Working knowledge of cGMPs and regulatory requirements is preferred
- Good mechanical aptitude
- Good interpersonal skills and the ability to work well in a team environment
- Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment
- Strong listening, writing, reading, and verbal communication skills
- Experience working with nasal spray products is a plus
- Experience with a variety of PLC and HMI hardware and applications
- Controls design experience
- General electrical design knowledge