Orano Med is seeking an Instrumentation Specialist for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.

The Instrumentation Specialist will be responsible for maintaining, calibrating, and ensuring the accurate operation of critical laboratory instrumentation. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability.

Responsibilities

• Perform routine maintenance, calibration, and troubleshooting of HPLC systems, lab balances, particle counters, viable air samplers, BMS, and various sensors.

• Ensure all instrumentation operates within specified parameters and maintains accurate records of maintenance and calibration activities.

• Conduct temperature mapping for storage areas, equipment, and facilities to ensure compliance with regulatory requirements.

• Ensure all instrumentation activities comply with relevant regulatory standards (e.g., FDA, GMP, ISO).

• Diagnose and resolve technical issues with instrumentation, working with vendors and service providers as necessary.

• Remote work may be possible when the facility is under construction.

Production

• Top priority: Daily routine production.

• Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc.

• Manufacturing activities following SOPs, using proper aseptic technique.

• Setup production; line clearance; clean/VPHP.

• Troubleshoot urgent problems.

• Identify, document, and communicate failures/near misses.

• Quality/continuous improvement.

• Adhere to SOPs, company policies, regulatory requirements, and laws.

• Quality/continuous improvement

Physical: Stand for 6+ hours, lift/move 50 lbs., and wear cleanroom PPE