Sr. QC Instrumentation Engineer - Eli Lilly and Company

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Description:  

To provide equipment lifecycle management support to the Lebanon Advanced Therapies QC Laboratories. Main support functions include specifying and purchasing equipment; authoring equipment qualification packages, managing the equipment qualification process, and providing daily operational support of laboratory equipment by ensuring the equipment is maintained in a qualified state of compliance. The position requires an understanding of corporate quality systems, a detail-oriented quality mindset with an understanding of analytical/micro laboratory equipment, knowledge of lab methods to understand intended use of equipment and their failure modes effects. High-quality skills to include equipment troubleshooting, ability to prioritize, written and oral communication, decision making, interpersonal/people, computer applications, and problem solving. 

Responsibilities: 

• Perform simple equipment maintenance following vendor and Lilly protocols in the QC Laboratories.
• Author, execute, and review equipment qualification/validation protocols and strategies for the QC Laboratories. 
• Support equipment lifecycle management and laboratory informatics initiatives guided by the LP2 QC Lab Strategy and global Lilly QC Lab Equipment Strategy documents. 
• Support equipment connectivity activities, integrating QC instrumentation with LIMS and e-Systems to achieve a paper-less laboratory. 
• Participate/lead in data integrity controls and improvement initiatives. 
• Communicate with other functions and external vendors regarding qualification issues and key operational objectives. 
• Act as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment. 
• Responsible for execution of laboratory CSV initiatives, System Administrator duties, system upgrades, and data integrity. 
• Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management. 
• Interact effectively with customers, support groups and development. 
• Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met. 
• Influence improvements and streamline quality systems relating to equipment. 
• Serve as equipment expert and technical resource in the review of technical documents. 

Basic Requirements: 

• Bachelor’s degree in a science or engineering related field (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, Automation, etc.) 
• 2+ years of equipment experience with emphasis on GMP instrumentation

Additional Preferences: 

• Experience supporting analytical equipment in a GMP environment
• Previous experience with managing data integrity regulations and controls 
• Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva 
• Working effectively with a cross functional group
• Excellent written and oral communication skills and ability to collaborate and interact with management, scientists, engineering and IT personnel
• Understanding of compliance requirements and regulatory expectations for GMP systems

Additional Information:  

• May be required to support the QC Lab during off hours on a rotating schedule.
• Applicant will work in various areas within the LP2 site. Some allergens are present in the site and Laboratory. Mobility requirements and exposure to allergens should be considered when applying for this position.

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