Associate - Operation Parenteral Filling

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 put people first and strive to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. We also develop creative solutions to support communities through philanthropy and volunteerism.

Lilly is investing over $1 Billion to build a new, highly automated campus in Concord, North Carolina, which will house warehousing & logistics, parenteral operations, medical device assembly, packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.

If you ever wanted to have a direct impact on building a team’s culture and how the team operates, now is the perfect opportunity!

During the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Parenteral (PAR) areas and lead/assist in operations readiness programs (e.g., material procurement and definition, training programs, operational excellence programs, establishing standard work programs, continuous improvement, and capacity planning). The PAR department will own product formulation, aseptic isolator barrier filling, and visual inspection operations. The person in this role will be the PAR area’s technical subject matter expert and will be involved in hiring and training personnel.

This position will require domestic travel with the opportunity for travel internationally to collaborate and learn from sites that produce our medicines currently.

Once the facility is turned over to operations, the OA is responsible for daily performance management and support of the PAR process team. This individual must ensure cross-functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the area. Above all else, the role will lead by example with a safety-first, quality-always approach.

As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles.

Integrity

• Lead by example with a safety-first, quality-always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product-impacting situation.
• Lead/conduct area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups.
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.

Excellence

• Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
• Lead and facilitate operations readiness activities and programs for the PAR portion of the business, including consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, and product flows throughout the facility.
• Participate in the development and implementation of strategies focused on Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area.
• Develop, monitor, and propose solutions to improve or meet key performance indicators (KPI) for the area.

Respect for People

• Support Site…