Lead - Parenteral Manufacturing Operations

Eli Lilly Eli Lilly · Pharma · Pleasant Prairie, WI

Lead role in parenteral manufacturing operations at Eli Lilly, focusing on operating equipment, providing frontline leadership, technical troubleshooting, and operator development. The role involves supporting commissioning, qualification, and operational readiness in a new facility, ensuring compliance with safety and production procedures, and driving departmental objectives. Requires experience in pharmaceutical or medical device manufacturing and knowledge of cGMPs.

What you'd actually do

  1. Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  2. Ensure strict compliance with established policies/procedures (Safety, Production Procedures, Sanitization, Gowning, etc.) and ensure operators are trained and qualified to perform tasks.
  3. Actively participate in commissioning and qualification activities as the site prepares for initial manufacturing operations, including equipment walkthroughs, procedure reviews, and operator readiness assessments.
  4. Partner with cross-functional teams (Engineering, TSMS, Quality, etc.) to support the transition from line ramp-up to routine production.
  5. Serve as the primary point of contact for unexpected floor events; lead troubleshooting and escalate issues to appropriate channels.

Skills

Required

  • High School Diploma or equivalent
  • Minimum 2 years relevant experience in pharmaceutical or medical device manufacturing
  • Knowledge of current Good Manufacturing Practices (cGMPs)
  • Authorized to work in the United States on a full-time basis

Nice to have

  • 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.

What the JD emphasized

  • 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 and visas for this role