Production Operator

OranoMed is seeking a Production Operator for the production team at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. 

The top priority for the Production Operator will be routine production. This position presents the opportunity to help establish a new facility that will meet high standards for quantity, speed, and reliability. 

Prior to routine operations:

• Work with Production team to improve the process
• Writing/reviewing relevant SOPs
• Implement new equipment, materials, software, systems
• Environmental qualification of new cleanrooms
• Complete: reading SOPs, gowning qualification, media fills, process training, bioburden runs, PV runs, tech transfer
• Remote work may be possible during the period the facility is under construction.

Once production begins:

• Top priority: Daily routine production
  o Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc.
  o Manufacturing activities following SOPs, using proper aseptic technique
  o Setup production; line clearance; clean/VPHP
  o Troubleshoot urgent problems
  o Identify, document, communicate failures/near misses
• Quality/continuous improvement
  o Adhere to SOPs, company policies, regulatory requirements, laws
  o Work closely with QC/QA to deliver quality product
  o Assist with deviations, OOT/OOS, CAPAs, change controls, audits, inspections
• Cross-train and perform
  o Cleanrooms: cleaning, EM, restocking
  o Packaging/labelling/driving/shipping of radioactive product
  o Routine radiation surveys, wipe tests
• Other
  o Maintain paper/electronic batch records, equipment logs, other records
  o Equipment: maintain, qualify, calibrate, prepare, report problems, troubleshooting
  o Maintain stock of materials/supplies; receive deliveries; obtain documentation for raw material release
  o Recruit/train new employees
  o Other tasks as needed