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

• Competitive compensation
• Health, Dental, and Vision insurance - with generous employer contributions
• 401(k) with employer matching and contribution amounts

• Life insurance and Short- and Long-Term Disability insurance provided by the company
• Generous Paid Time Off and holiday schedules
• Numerous Training and Development opportunities

• and more...

Required

• Experience
  • Hands-on GMP production of sterile pharmaceuticals: 2+ yrs
  • Cleanroom operations: gowning, cleaning, EM, aseptic technique
  • Follow detailed SOPs, complete detailed documentation (e.g., batch records), patiently revise per QA
  • QMS in a regulated environment: QA, GDP, SOPs, document control, change control
    
    
• Personality
  • Character: safety; integrity; honesty; respect authority; obey rules/policies
  • Owns the manufacturing process; work well in a fast-paced, high-pressure environment with tight deadlines
  • Attention to detail; meticulous execution/documentation
  • Attendance: dependable, on time; flexible for variable schedule
  • Work well under direct supervision or independently
  • Time management
• Physical
  • Stand for 6+ h
  • Lift/move 50 lbs repeatedly/routinely
  • Wear cleanroom PPE

Preferred

• Experience
  
  • Safety: occupational, laboratory, chemical, radiation
  • Production of radiopharmaceuticals
  • Automation: chromatography, dispensing
  • IT/IS: eBR, eQMS, EMS, etc.
  • Disposal of chemical/RAM waste
  • Shipping RAM
    
    
• Personality
  
  • Culture: Quality, Team, Service, Problem Solving
  • Teachable, accepts feedback; take responsibility with few excuses
  • Eager to learn new processes, accept projects, help with tasks
  • Identify problems, take initiative to solve them; push through challenges, ask for help
• Driving: valid license; comfortable driving

Orano Med encourages applicants with military experience.