Role Summary
The Manufacturing Chemical Operator for Lebanon API will be responsible for the production of API molecules at Lillyβs startup greenfield site, upholding a safety-first, quality-always mindset while running a production process that includes a wide range of unit operations. This role supports the startup and early GMP operations, collaborating with maintenance, technical support, and cross-functional teams to build processes and systems for GMP manufacturing.
Responsibilities
- 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 to ensure equipment and systems are in good operating condition and maintained per regulatory requirements.
- Understand Health, Safety & Environmental (HSE) requirements and apply Safety/Process Safety standards to execute GMP duties.
- Understand other area processes and their operational hazards and react appropriately.
- Monitor and collect data on equipment use and performance to anticipate potential reliability problems.
- Work with Maintenance and Technical Support to respond to potential production upsets or equipment failures.
- Contact appropriate personnel if there is a problem or event (spill/deviation/incident) during processing.
- Communicate with other shifts regarding the status of area operations and handover details.
- Participate in daily shift huddles/meetings to understand and set daily operational goals.
- Participate in 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).
- Follow cGMP practices, safe work habits, dress code, hygiene standards, and housekeeping requirements specific to the work area.
- Use company-supplied personal protective equipment (PPE) for long periods as required.
Qualifications
- Required: High School Diploma or equivalent.
- Required: Legally authorized to work in the United States (no visa sponsorship expected).
- Required: Completion of Post Offer Exam or Work Simulation if applicable.
- Preferred: Previous experience in facility/area start-up environments.
- Preferred: Experience in pharmaceutical manufacturing with PSM-regulated/hazardous chemicals; strong understanding of FDA guidelines and cGMP.
- Preferred: Strong organizational skills; ability to prioritize; knowledge of lean manufacturing principles.
- Preferred: Emergency Response Experience; Indiana State or IFSAC Certification β Fire 1, Hazmat Technician; effective communication skills; basic computer skills.
Skills
- Strong communication (written and verbal) and ability to work with cross-functional teams.
- Ability to understand technical nomenclature and mathematical concepts; proficiency with desktop software.
- Analytical thinking with ability to monitor equipment data and troubleshoot issues.
- Manual material handling capability; ability to bend, reach, climb ladders, and work in tight spaces.
- Ability to work 12-hour rotating shifts and flexible schedules during startup; overtime as required.
Education
- High School Diploma or equivalent
Additional Requirements
- Ability to work 12-hour rotating shifts.
- Ability to work flexible schedules during startup period.
- Ability to work overtime as required.
- May require short-term domestic or international assignment (1β6 months) to train and certify on processes; possible short travel (<1 month) to support equipment testing.