Manufacturing Specialist - Deviations

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$64,500 - $140,800

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.   

Responsibilities: 

The Operations Associate (OA) will report to the Director of Operations (Formulation and Filling). The OA will be responsible for providing leadership within the area’s process team, managing projects and process improvements, acting, as a liaison between operations and multiple functional groups to support event management, change controls, etc.  The OA will lead investigations and drive implementation of actions associated with deviations. 

  

Operations Associate is responsible the daily performance management of the process team. This individual must ensure a cross functional collaboration between operations, engineering, quality, supply chain, and maintenance.  The OA will establish and hold the process team accountable for key metrics and deliverables to ensure the process is meeting expectations and actioning improvements for the process. Strict adherence to safety and quality rules and procedures is required.   

Key Objectives 

• Monitor and build a strong safety culture.
• Monitor and maintain process team compliance records (deviations, CAPAs, change controls, etc).
• Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral Manufacturing areas. 
• Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations. 
• Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). 
• Understand and influence the manufacturing control strategy for their area. 
• Lead and facilitate start up activities regarding site operational readiness for the Parenteral portion of the business 
• Lead area tours to support business reviews and / or regulatory audits 
• Trained as a Lead Investigator 
• Development and monitoring of metrics for the area 
• Aid in issue resolution, batch/product approvals, and production schedule execution. 
• Lead specific activities of the process teams. 
• Potential back-up to the Process Team Leader

Basic Requirements: 

• Bachelor’s degree 
• Experience: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals ​
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. 

Additional Skills/Preferences: 

• Bachelor’s degree in science, engineering, or technical field 
• Previous experience in facility/area start-up environments 
• Career interests in Operations Leadership 
• Certified Six Sigma Green/Black Belt 
• Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA. 
• Excellent interpersonal, written and oral communication skills 
• Ability to work in a controlled environment (classified and non-classified) which requires specific company provided gowning. 
• Previous experience with EMPQ requirements of classified areas and in-operation EM Program 
• Experience with root cause analysis, technical writing / authoring investiga