Production Operator Lilly Medicine Foundry

About the role

The Lilly Medicine Foundry is a new center for advanced manufacturing and drug development, combining research and manufacturing in a single location. The role of the Manufacturing Operator involves supporting the start-up activities to bring manufacturing equipment into service, becoming an expert in their assigned area, and overseeing the production of API molecules once the project phase is completed.

Responsibilities

• Support daily activities to meet production plans by adhering to compliance requirements, operating 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 monitor 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.
• 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

• HS Diploma/GED
• 2+ years of API manufacturing experience

Qualifications

• Authorized to work in the United States on a full-time basis
• 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