Manufacturing Operator - Lebanon API

Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.

We’re looking for people who are determined to make life better for people around the world.

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 a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.

• Maintain compliance with regulatory requirements at all times.
• Support the execution of the production plan for the site.
• Carry out daily monitoring testing and cleaning duties as assigned to ensure equipment and systems are in good operating conditions and are maintained in accordance with local and corporate regulatory requirements.
• Understand Health, Safety & Environmental (HSE) requirements and the application of Health & Safety/Process Safety standards in order to execute GMP duties.
• Understand other area processes & their operational hazards and being able to react appropriately.
• Monitor and collect data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems.
• Work with Maintenance and Technical Support to respond appropriately to potential production upsets or equipment failure.
• Contact the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.
• Communicate with other shifts regarding the status of the area operations and details of any issues/problems that have occurred at handover.
• Participate in daily shift huddles / meetings to both understand and set expectations for daily operational goals.
• Actively participate in assigned building & area operations such as safety audits, procedure co-ordination, 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.
• Must be able to use specified company supplied personal protective equipment (PPE) for long periods of time.

• 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 for this employment position.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Ability to effectively communicate (electronically, written and verbal).
• Basic computer skills (desktop software) are required.
• Manual material handling as appropriate.
• Bend, reach, stretch, climb ladders, and work in tight spaces.
• Stand for long periods as needed.

• Previous experience in facility/area start-up environments.
• Previous experience in a pharmaceutical manufacturing operation with PSM-regulated/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 – ability to troubleshoot and triage challenges
• Ability to understand technical nomenclature and language as well as work with mathematical formulas.
• Emergency Response Experience
• Industrial, military, volunteer, career firefighter
• Indiana State or IFSAC Certification – Fire 1, Hazmat…