Production Operator - 228603

**Need to have radiopharmaceutical/radiation/radioactive experience in order to be considered**

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
• 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, communicate failures/near misses
• Quality/continuous improvement
• Adhere to SOPs, company policies, regulatory requirements, laws
• Work closely with QC/QA to deliver quality product
• Assist with deviations, OOT/OOS, CAPAs, change controls, audits, inspections
• Cross-train and perform
• Cleanrooms: cleaning, EM, restocking
• Packaging/labelling/driving/shipping of radioactive product
• Routine radiation surveys, wipe tests
• Maintain paper/electronic batch records, equipment logs, other records
• Equipment: maintain, qualify, calibrate, prepare, report problems, troubleshooting
• Maintain stock of materials/supplies; receive deliveries; obtain documentation for raw material release
• Recruit/train new employees