Lead Operator

Lead Operator – Bio Space

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Lilly is currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly’s largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be part of the startup team for a greenfield manufacturing site, and the successful candidate will help build the processes and facility to enable a successful startup into GMP manufacturing operations.

The Lead Operator for API manufacturing operations is directly responsible for the production of API molecules used in Lilly medicines. The Lead Operator will uphold a safety-first, quality-always mindset while running a production process that incorporates a wide range of unit operations. During the project delivery and startup phase (expected 2025‑2027), roles will be fluid and dynamic as we build a new organization, develop and implement the necessary systems and business processes, and create the site culture.

Success requires significant collaboration, creativity, and resilience.

• Maintain compliance with all regulatory requirements at all times.
• Support the execution of the production plan for the site.
• Carry out daily monitoring, testing and cleaning duties to ensure equipment and systems are in good operating condition and are maintained in accordance with local and corporate regulatory requirements.
• Enter Trackwise events and participate in and lead CAPA investigations.
• Troubleshoot and diagnose process problems and take appropriate actions to minimize deviations or site impact.
• Understand Health, Safety & Environmental regulated environment and application of Health & Safety/Process Safety standards to execute key/critical GMP duties.
• Understand other area processes & their operational hazards and react appropriately.
• Monitor and collect data on equipment use and performance to anticipate potential equipment reliability problems.
• Work with Maintenance and Technical Support to respond to potential utility supply upsets or equipment failure.
• Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.
• Communicate to other shifts regarding the status of the area operations and details of any issues/problems at handover.
• Actively participate in assigned building & area operations such as safety audits, procedure coordination, housekeeping and improvement projects.
• Be trained and qualified on all specified unit operations within the building.
• Identify concerns for informal or formal discussion (shift meetings, safety representative).
• Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and housekeeping requirements unique to the work area and job classification.

• High School Diploma or equivalent.
• Qualified candidates must be legally authorized to be employed in the United States;
  Lilly does not anticipate providing sponsorship for employment visa status (e.g., H‑1B or TN status).
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Ability to effectively communicate electronically, written and verbally.
• Basic computer skills (desktop software) are required.
• Minimum 3 years previous experience in operations.

• Previous experience in facility/area start‑up environments.
• Previous experience in a pharmaceutical manufacturing operation with PSM‑regulated/hazardous chemicals.
• Ability to assume leadership and prioritize daily priorities without direct supervision.
• 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 – ability to troubleshoot and triage challenges.
• Ability to understand technical nomenclature and language as well as work with mathematical formulas.
• Manual material handling as appropriate.
• Bend, reach, stretch, climb ladders, and work in…