Company: Summit Biosciences Inc.
Posted on: January 16, 2022
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
The Maintenance Engineer is responsible for performing and/or
leading a wide array of troubleshooting, continuous improvement and
reliability centered maintenance and calibration programs in a
pharmaceutical cGMP facility. -This is a hands-on position which
also includes developing and streamlining maintenance programs,
coordinating change management, and performing higher level
troubleshooting. -The successful Maintenance Engineer/Specialist
will troubleshoot equipment, utility, and facility issues and
proactively improve existing and new equipment, utilities, and
facilities.Specific activities include working with all personnel
to identify and determine solutions for maintenance in the
manufacturing, laboratory, and office areas. -This includes
following and revising procedures, forms, routine maintenance,
preventative maintenance, and instrument calibration. -This person
will assist with emergency repairs, spare parts identification, and
will have technical input for new equipment purchases and plant
- Support Maintenance activities, including review and approval
of preventative maintenance tasks, calibration tolerances and
intervals, drawing updates, execution of PMs and support of
out-of-tolerance investigations related to instrument
- Continuously evaluate the effectiveness of maintenance and
calibrations to identify the need to upgrade or change processes
for maintaining equipment, utilities, and facilities to achieve
best in class reliability.
- Provide support to Manufacturing, Quality, Engineering, and
Validation for deviation investigations, change controls and CAPA's
through participation on cross functional teams
- 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.
- Assist in the design and procurement of new process and utility
equipment including participating in the installation, start-up,
commissioning, or qualification activities.
- Discover, evaluate, and recommend mechanical, electrical,
control system or equipment upgrades to continually improve
quality, safety, and reliability and reduce costs.
- Participate in design reviews of plant expansions or process
changes, and serve as a technical point of contact or user
representative for contract services
- Evaluate spare parts needed and assist in maintaining an
adequate inventory for all plant and manufacturing equipment.
- Keep all plant systems and manufacturing equipment operating
efficiently and well maintained. -
- Operate, monitor, calibrate and maintain equipment and systems
used to support operations.
- Complete emergency repairs in a high quality, timely manner to
- Complete PM records, equipment logs and other forms to document
- Maintain assigned areas neat and orderly and in compliance with
SOPs and cGMPs.
Keywords: Summit Biosciences Inc., Lexington , Maintenance Engineer, Engineering , Lexington, Kentucky
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