Lead Operator - Solvent Recovery Operations

Role Summary

The Lead Operator for Solvent Recovery Operations is directly responsible for ensuring that the supply of solvents and management of waste is provided without interruption of service to support the needs of the facility. The role oversees solvent recovery operations, air emissions systems, and associated supply and waste tanks, executing operations per SOPs to safely and compliantly support the manufacturing of high-quality medicine.

Responsibilities

• Ensure operations maintains compliance with all regulatory requirements at all times.
• Ensure areas appropriately support the execution of the production plan for the site.
• Solvent Recovery Units, Cryogenic Units
• Carry out daily monitoring testing and cleaning duties as assigned on the above listed systems to ensure equipment and systems are in good operating conditions and they are maintained in accordance with local and corporate regulatory requirements.
• Enter Trackwise/Veeva events, 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 in order to execute key/critical GMP duties.
• Understand other area processes & their operational hazards and being able to react appropriately.
• Monitoring and collecting data on equipment use and performance i.e. trying to anticipate potential equipment reliability problems.
• Working with Maintenance and Technical Support to respond appropriately to potential utility supply upsets or equipment failure.
• Contacting the appropriate help if there is a problem or an event (spill/deviation/incident) during processing.
• Communication to 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 participating 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 area. Support training and qualification for operators in the area.
• Identify concerns for informal or formal discussion (crew 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.

Qualifications

• 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) for this employment position.
• Completion of Post Offer Exam or Completion of Work Simulation if applicable.
• Minimum 3 years of previous experience in utility/tank farm/solvent recovery/distillation operations or chemical manufacturing
• Ability to effectively communicate (electronically, written and verbal).
• Basic computer skills (desktop software) are required.
• Bend, reach, stretch, climb ladders, and work in tight spaces.
• Stand for long periods.

Additional Preferences

• Previous experience in facility/area start-up environments
• 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
• Emergency Response Experience Industrial, military, volunteer, career firefighter
• Indiana State or IFSAC Certification – Fire 1, Hazmat Technician

Additional Information

• Ability to work 12-hour rotating shifts (days and nights)
• Ability to work flexible schedules during startup period
• Ability to work overtime as required
• Depending on the candidate’s experience, the position may require a short-term assignment of 1-3 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer’s factory.