Lead - Parenteral Manufacturing Operations

Eli Lilly and Company • Pleasant Prairie, WI

9d • Onsite

About The Position

The Filling Operations Teams are an essential part of Lilly’s Kenosha County (LKC) Parenteral Manufacturing site. We manufacture and fill injectable parenteral products in state-of-the-art facilities to supply patients around the world. This position will work in a new facility with best in class, globally replicated production equipment. Operations team members will work with the latest industry technologies, while learning from global teams, to manufacture key current parenteral products and preparing for upcoming products. The Lead is a working leader, operating equipment alongside the team while providing frontline leadership on the manufacturing floor. This role serves as the primary point of contact for shift-level operations, technical troubleshooting, and operator development. The Lead is also the designated backup for the Supervisor. During line ramp-up activities, the Lead will serve as a subject matter expert for area equipment and processes, actively supporting commissioning, qualification, and operational readiness activities required to bring manufacturing areas into service. Given the multi-year nature of the LKC ramp-up, this work will remain a meaningful component of the role well beyond initial line startup.

Requirements

• High School Diploma or equivalent
• Minimum 2 years relevant experience in pharmaceutical or medical device manufacturing
• Knowledge of current Good Manufacturing Practices (cGMPs)
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Nice To Haves

• Prior experience in parenteral, aseptic, or sterile manufacturing environments.
• Strong working knowledge of GMPs, quality systems, and documentation practices in a regulated manufacturing setting.
• Experience supporting investigations, deviations, and implementation of corrective and preventive actions.
• Familiarity with root cause analysis and structured problem-solving methods.
• Comfort working in classified areas (e.g., isolators, Grade C environments) and reinforcing proper technique and compliance.
• Familiarity with parenteral filling equipment and associated systems, including isolators, filling/stoppering/capping/lyophilization equipment, cleaning and sterilization systems, filter integrity testers, formulation equipment, and analytical devices.
• Demonstrated ability to train, mentor, and develop hourly operations personnel.
• Experience in a working leader capacity, performing hands-on tasks while guiding team performance.
• Ability to set expectations, maintain operational discipline, and drive accountability on the shop floor.
• Strong judgment and escalation skills in safety, quality, and operational decision-making.
• Proven ability to work cross-functionally with Quality, TSMS, Engineering, Maintenance, Supply Chain, etc.
• Effective communicator with the ability to translate procedures and expectations into clear direction for operators.
• Adaptability to support new equipment, process changes, and capital project activities.
• Computer proficiency and comfort using enterprise systems and quality management systems (such as SuccessFactors, Veeva Vault, MasterControl, TrackWise, SAP).

Responsibilities

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Ensure strict compliance with established policies/procedures (Safety, Production Procedures, Sanitization, Gowning, etc.) and ensure operators are trained and qualified to perform tasks.
• Actively participate in commissioning and qualification activities as the site prepares for initial manufacturing operations, including equipment walkthroughs, procedure reviews, and operator readiness assessments.
• Partner with cross-functional teams (Engineering, TSMS, Quality, etc.) to support the transition from line ramp-up to routine production.
• Serve as the primary point of contact for unexpected floor events; lead troubleshooting and escalate issues to appropriate channels.
• Assist Supervisor in development and performance evaluations of shift operators; provide day-to-day coaching and mentorship.
• Coordinate and deploy technical training to ensure operators are qualified to perform assigned tasks.
• Leads and participates in structured problem-solving (root cause analysis, countermeasure development, etc.) to improve safety, quality, and operational performance.
• Assist in checking execution documentation (MasterControl, SAP, Cleaning Logs, etc.) for accuracy and compliance.
• Drive key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
• Network with various support areas to verify components and equipment are available for production orders.
• Ensure adherence to use of proper technique in isolator and Grade C operational areas.
• Other duties, as assigned.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

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