Manufacturing Operator - Lebanon API

Role Summary

Manufacturing Operator for API at a greenfield site in Lebanon, IN. Responsible for production of API molecules with a safety-first, quality-always mindset and operating a production process that includes a wide range of unit operations. Part of startup team building processes and systems to enable GMP manufacturing operations.

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 as assigned to ensure equipment and systems are in good operating condition and maintained per local and corporate regulatory requirements.
• Understand Health, Safety & Environmental (HSE) requirements and apply Health & Safety/Process Safety standards to execute GMP duties.
• Understand other area processes and their operational hazards and respond appropriately.
• Monitor and collect data on equipment use and performance to anticipate potential reliability problems.
• Work with Maintenance and Technical Support to respond to production upsets or equipment failure.
• Contact the appropriate help if there is a problem or event (spill/deviation/incident) during processing.
• Communicate with other shifts regarding the status of area operations and details of issues at handover.
• Participate in daily shift huddles/meetings to understand and set daily operational goals.
• Participate in building and 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 discussions (shift meetings, safety representative).
• Follow cGMP practices, safe work habits, dress code, hygiene standards, and housekeeping requirements.
• Use company supplied PPE for extended periods.

Qualifications

• High School Diploma or equivalent
• Legally authorized to be employed in the United States
• Completion of Post Offer Exam or Work Simulation if applicable
• Effective communication (electronic, written and verbal)
• Basic computer skills
• Manual material handling; bend, reach, stretch, climb ladders; work in tight spaces
• Stand for long periods as needed

Additional Preferences

• Experience in facility/area start-up environments
• Experience in pharmaceutical manufacturing with PSM-regulated/hazardous chemicals
• Understanding of FDA guidelines and cGMP
• Strong organizational skills and ability to handle multiple requests
• Knowledge of lean manufacturing principles
• Flexibility to troubleshoot and triage challenges
• Ability to understand technical nomenclature and mathematical formulas
• Emergency Response Experience; background in industrial, military, volunteer firefighting
• Indiana State or IFSAC Certification ‚Äì Fire 1, Hazmat Technician

Education

• High School Diploma or equivalent

Additional Requirements

• Ability to work 12-hour rotating shifts
• Flexible schedules during startup period
• Ability to work overtime as required
• Possibility of short-term domestic or international assignments (1‚Äì6 months) for training; potential short travel for equipment testing