Production Operator Lilly Medicine Foundry

Role Summary

The Lilly Medicine Foundry Manufacturing Operator actively supports start-up activities to bring manufacturing equipment into service. The Operator becomes an expert in their assigned area, Small Molecule, Hybrid, or Biologics, and educates the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs. Upon completion of the project phase, the Operator directly oversees the production of API molecules with a safety-first, quality-always approach across diverse unit operations and manufacturing skills.

Responsibilities

• Adhering to compliance requirements (safety, quality, and environmental) and appropriately communicating/troubleshooting any adverse events.
• Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet production schedule.
• Performing daily monitoring, testing, and cleaning duties to ensure equipment and systems are in good operating condition and maintained per local and corporate regulatory requirements.
• Understanding Health, Safety & Environmental (HSE) requirements and applying Health & Safety/Process Safety standards to execute GMP duties.
• Recognizing other area processes and their operational hazards and reacting appropriately.
• Monitoring and collecting data on equipment use and performance to anticipate potential reliability problems.
• Contacting the appropriate help if there is a problem or event (spill, deviation, incident) during manufacturing.
• Communicating with other shifts regarding the status of area operations and any issues/problems that have occurred at handover.
• Participating in daily shift huddles/meetings to understand and set expectations for daily operational goals.
• Actively participating in assigned building and area operations such as safety audits, procedure coordination, housekeeping, and continuous improvement projects.
• Following cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.
• Using specified company-supplied personal protective equipment (PPE) as required.

Qualifications

• HS Diploma/GED
• 3+ years of manufacturing experience, GMP and/or chemical processing preferred.
• Qualified candidates must be legally authorized to be employed in the United States.

Additional Skills

• Previous experience in facility or area start-up environments.
• Previous experience in a pharmaceutical or chemical manufacturing operation involving PSM-regulated or hazardous chemicals.
• A solid understanding of FDA guidelines and cGMP requirements.
• Strong organizational skills with the ability to handle and prioritize multiple requests.
• Knowledge of lean manufacturing principles.
• Flexibility to troubleshoot and triage challenges effectively.
• The ability to understand technical nomenclature and language, as well as work with mathematical formulas.

Additional Information

• Position Location: US: Lebanon IN Lilly Medicine Foundry Operations initial location in Indianapolis, IN during pre-startup phase
• Travel Percentage: 5%
• Must be able to work a 12-hour rotating shift
• May be required to provide support outside of normal working hours including nights, weekends, and holidays.