Lead Operator - Tank Farm, Truck & Rail Operations

Role Summary

The Lead Operator for Tank Farm, Truck and Rail Operations is responsible for ensuring the supply of solvents and management of waste is provided without interruption to support the needs of the facility. The role includes tank farm operations, air emissions systems, and truck/rail car loading/unloading, executing operations per SOPs to safely and compliantly support GMP manufacturing of high-quality medicine. During the project delivery and startup phases (startup expected 2026–2028), the position will be fluid and dynamic as the site builds its organization, systems, and culture toward full-scale GMP operations.

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.
• Tank Farm operations, tanker loading/unloading, railcar loading/unloading
• 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

• Required: High School Diploma or equivalent
• Required: Legally authorized to be employed in the United States
• Required: Completion of Post Offer Exam or Completion of Work Simulation if applicable
• Required: Minimum 3 years of experience in utility/tank farm/truck and rail loading and unloading operations or chemical manufacturing
• Required: Ability to effectively communicate (electronic, written and verbal)
• Required: Basic computer skills (desktop software)
• Required: Bend, reach, stretch, climb ladders, and work in tight spaces; Stand for long periods
• Preferred: Previous experience in facility/area start-up environments
• Preferred: Ability to assume leadership and prioritize daily priorities without direct supervision
• Preferred: Solid understanding of FDA guidelines and cGMP requirements
• Preferred: Strong organizational skills and ability to handle and prioritize multiple requests
• Preferred: Knowledge of lean manufacturing principles
• Preferred: Emergency Response Experience
  • Industrial, military, volunteer, career firefighter
  • Indiana State or IFSAC Certification – Fire 1, Hazmat Technician