Operator - Solvent Recovery Operations

Role Summary

The Solvent Recovery Operator 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 involves solvent recovery operations, air emissions systems, and associated supply and waste tanks, executing operations per SOPs and operational execution instructions to safely and compliantly support GMP manufacturing of high-quality medicine.

This role supports startup and project delivery phases, collaborating to build processes, systems, and a culture aligned with GMP operations.

• 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 Unit, 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.
• 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 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.
• 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.

• Required:
  
  High School Diploma or equivalent
• Required:
  
  Legally authorized to work in the United States
• Required:
  
  Effective communication (electronic, written, and verbal) and basic computer skills
• 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:
  Previous experience in distillation unit operations or similar unit operations
• Preferred:
  Solid understanding of FDA guidelines and cGMP requirements
• Preferred:
  Strong organizational skills and ability to prioritize multiple requests
• Preferred:
  Knowledge of lean manufacturing principles
• Preferred:
  Emergency Response Experience (industrial, military, volunteer, career firefighter)
• Preferred:
  Indiana State or IFSAC Certification – Fire 1, Hazmat Technician

• High School Diploma or equivalent

• Ability to work 12-hour rotating shifts (days and nights)
• Ability to work flexible schedules during startup period
• Ability to work overtime as required
• Possible short-term assignments or travel during startup/training periods (domestic or international) as needed