Production Operator Lilly Medicine Foundry

Responsibilities

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

Requirements

• High School Diploma or equivalent.
• 2+ years of API manufacturing experience required.
• 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.
• The ability to troubleshoot and triage challenges effectively.
• The ability to understand technical nomenclature and language, as well as work with mathematical formulas.

Qualifications

• Must be authorized to work in the United States on a full-time basis.
• 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. Permanent schedule will be a 12-hour 2-3-3-2 schedule, alternating every 8 weeks between day and night shift.
• May be required to provide support outside of normal working hours including nights, weekends, and holidays.