API Production Operator - Lilly Medicine Foundry

Lilly•Lebanon, IN
•$18 - $35

About The Position

The Lilly Medicine Foundry Manufacturing Operator supports the startup of a new manufacturing site by helping bring manufacturing equipment into service, developing expertise in an assigned area (Small Molecule, Hybrid, or Biologics), and educating the team on proper facility operations. During project delivery and startup, operational duties may be fluid as the organization develops systems, processes, and site culture. The position requires domestic and international travel to collaborate with, train, and learn from sites that currently produce APIs. After the project phase, the Operator directly oversees production of API molecules, applying a safety-first, quality-always approach across diverse unit operations and manufacturing activities. Operators support production plans by operating and monitoring equipment, maintaining compliance and safe work practices, troubleshooting and escalating events, and communicating with colleagues across shifts. The position is based in Lebanon, Indiana, with an initial pre-startup location in Indianapolis, Indiana. Travel is 5%. The role works a 12-hour rotating shift on a 3-2-2-3 schedule, rotating between days and nights every eight weeks, and may require support outside normal hours, including nights, weekends, and holidays. The anticipated wage is $18.02–$35.43. Eligible full-time employees may receive a company bonus and benefits including 401(k), pension, vacation, medical, dental, vision, prescription drug coverage, flexible spending accounts, life and death benefits, time off and leave benefits, and well-being benefits.

Requirements

  • High school diploma or GED.
  • At least 3 years of API manufacturing experience; GMP and/or chemical processing experience is preferred.
  • Must be legally authorized to work in the United States; employment visa sponsorship is not anticipated.
  • Ability to work a 12-hour rotating shift on a 3-2-2-3 schedule, rotating between day and night shifts every eight weeks.
  • Ability to provide support outside normal working hours, including nights, weekends, and holidays, as required.

Nice To Haves

  • Previous experience in facility or area startup environments.
  • Previous experience in pharmaceutical or chemical manufacturing involving PSM-regulated processes or hazardous chemicals.
  • Solid understanding of FDA guidelines and cGMP requirements.
  • Strong organizational skills and ability to handle and prioritize multiple requests.
  • Knowledge of lean manufacturing principles.
  • Flexibility to troubleshoot and triage challenges effectively.
  • Ability to understand technical nomenclature and language and work with mathematical formulas.

Responsibilities

  • Support startup activities to bring manufacturing equipment into service and help develop the systems and processes required for GMP operations.
  • Become an expert in an assigned Small Molecule, Hybrid, or Biologics area and educate the team on proper facility operation.
  • Oversee production of API molecules after the project phase, supporting production plans and schedules.
  • Follow safety, quality, environmental, and other compliance requirements, and communicate or troubleshoot adverse events appropriately.
  • Operate processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions.
  • Perform daily equipment and system monitoring, testing, and cleaning, maintaining equipment in good operating condition and in accordance with regulatory requirements.
  • Apply Health, Safety & Environmental requirements and Health & Safety/Process Safety standards while performing GMP duties.
  • Recognize hazards associated with other area processes and react appropriately.
  • Monitor and collect equipment-use and performance data to anticipate potential reliability problems.
  • Contact appropriate support when manufacturing problems or events occur, including spills, deviations, or incidents.
  • Communicate area status and issues with other shifts during handover.
  • Participate in daily shift huddles and meetings to understand and establish operational goals.
  • Participate in building and area operations, including safety audits, procedure coordination, housekeeping, and continuous improvement projects.
  • Follow cGMP practices, safe work habits, plant dress code, hygiene standards, and area-specific housekeeping requirements.
  • Use required company-supplied personal protective equipment.

Benefits

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