Lead Operator, Aseptic Filling (Day Shift)

Lilly • Concord, NC

4d • $27 - $40 • Onsite

About The Position

Lilly is building a new, highly automated and environmentally conscious manufacturing campus in Concord, North Carolina, to expand capacity for parenteral medicines, device assembly, and packaging. During the project phase, the Parenteral (PAR) Lead Operator supports startup activities to bring the aseptic isolator barrier filling area into service, develops expertise in the assigned area, educates team members in facility operations, and leads training on PAR equipment and processes.

After startup, the Lead Operator helps ensure continuous medicine supply by operating and troubleshooting processes, collaborating across functions, and maintaining a safety-first and quality-always mindset. The role coordinates daily activities to meet capacity plans while developing individual and team capabilities. As a manufacturing-floor leader and technical expert, the Lead Operator supports safety, quality, productivity, training, operational procedures, and improvement objectives, and may serve as backup for the Supervisor.

Requirements

• High school diploma or GED.
• Ability to communicate effectively electronically, in writing, and verbally.
• Flexibility and ability to troubleshoot and triage challenges.
• Computer proficiency, including desktop software and Microsoft Office.
• Ability to work the day-shift schedule of 6 a.m. to 6 p.m. on a 2-2-3 schedule.
• Ability to work overtime as required.
• Ability to wear safety equipment such as glasses, shoes, and gloves.
• Ability to work and gown in a Grade C, ISO 8 cleanroom environment.
• Qualified candidates must be legally authorized to work in the United States; Lilly does not anticipate sponsoring employment visas for this position.

Nice To Haves

• Leadership experience or ability to train and educate team members.
• Experience with, completion of, or understanding of aseptic filling, single-use assemblies, and isolator technology.
• Experience with highly automated equipment, such as inspection, packaging, filling, or assembly equipment.
• Knowledge of current Good Manufacturing Practices (cGMPs).
• Experience in operations or manufacturing in the pharmaceutical, medical device, or food processing industries.
• Experience with Manufacturing Execution Systems and electronic batch release.
• Knowledge of continuous improvement methods, including Lean or Six Sigma.
• Experience with SAP and Electronic Batch Records.
• STEM degree or certifications.

Responsibilities

• Support startup activities required to bring the aseptic isolator barrier filling area into service.
• Develop expertise in the assigned area and educate the team in proper facility operation.
• Lead training of new staff on PAR equipment and processes; administer technical training and ensure operators are trained to perform tasks.
• Provide manufacturing-floor leadership to maintain safety, quality, productivity, and reliable product supply.
• Maintain a safe work environment, exemplify safe practices, and support HSE goals.
• Serve as an operations administrator and technical leader, demonstrate knowledge of procedures and quality systems, and teach proper techniques.
• Troubleshoot issues and act as a primary point of contact for shop-floor escalation.
• Operate equipment and perform activities required to meet the production schedule.
• Assist in checking execution documentation, including Electronic Batch Records, SAP, and cleaning logs.
• Drive departmental objectives such as improving safety performance, reducing deviations, improving productivity, and meeting training compliance.
• Support site leadership in developing area operational procedures, quality processes, and controls for PAR areas.
• Assist the Supervisor with development and performance evaluations of shift operators and act as backup for the Supervisor.
• Serve as a key liaison between operations and support functions.
• Coordinate daily activities to meet capacity plans and develop team capabilities.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefit eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED