Maintenance Engineer - Kindeva Drug Delivery/Summit Biosciences

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 expansion activities.

Essential Duties:

• 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 calibrations
• 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. 
• Optimization and troubleshooting of HVAC systems and equipment.
• Operate, monitor, calibrate and maintain equipment and systems used to support operations.
• Complete emergency repairs in a high quality, timely manner to minimize downtime.
• Complete PM records, equipment logs and other forms to document work activities.
• Maintain assigned areas neat and orderly and in compliance with SOPs and cGMPs.
• Write and revise SOPs and Forms to maintain up to date and accurate records.
• Other duties as assigned.

Qualifications

• Must be organized, flexible, adaptable, self-motivated, and able to work well independently, across teams and with partners.
• Ability to maintain focus on tasks until completion and think analytically to solve problems while paying attention to the details.
• Ability to work in a lean, action oriented organization and demonstrate a strong work ethic.
• Working knowledge of cGMPs and regulatory requirements is preferred.
• Minimum 2-5 years of previous work experience in a related field.
• Strong listening, writing, reading, and verbal communication skills.
• Experienced with Microsoft Word, Excel, and PowerPoint.
• PLC troubleshooting and programming is preferred.
• Strong mechanical and electrical aptitude.
• AA or BS in engineering or relevant experience.
• Pharmaceutical experience is preferred.
• HVAC training or certification is preferred