Orano Med:

Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

Job Summary:

Orano Med is seeking an Instrumentation Specialist, CQV or Sr. Instrumentation Specialist, CVQ for ATLab Indianapolis, a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability.

Job Responsibilities:

• Oversee IQ/OQ/PQ for new instruments
• Draft/review/approve documents related to CQV (SOPs, calibration certificates, IQ/OQ/PQ protocols, completed IQ/OQ/PQ reports)
• Equipment/service logs: establish, review, maintain
  URS for equipment: Assist with drafting/review/approval
• Responsible for a variety of cGMP and non-cGMP instruments including:
  • Production: preparatory LC, fluid transfer, dispensing, weighing, EM
  • QC: LC, HPGe, gamma counter, sterility, analytical balances, pipettes
  • Hot cells: VPHP, EM, fill/finish, other sensors/controls
  • Safety: radiation detectors for personnel, surfaces, air
  • General: refrigerators/freezers, incubators
• Assist with cGMP aspects of facilities equipment/sensors/controls: hot cells/cleanrooms/HVAC, temperature/RH, particle counters, fume hoods, access control, etc.
• Work with instrument operators to develop robust protocols for system suitability checks for equipment
• Assist with vendor qualifications
• Top Priority: On-Time Production/Release of Product Batch Release
• All tasks from the Setup Phase that continue into Production Phase.
• Carrying out/supervising calibration procedures and equipment maintenance to ensure that instruments maintain their qualified status.
• Preparation of calibration certificates and data reports using appropriate Quality documentation.
• Ensuring that the equipment is calibrated as per specifications and industry standards.
• Oversee warranties, PMs, scheduled recalibration/requalification
• Scheduling appointments for equipment maintenance and servicing.
• Troubleshooting and repairing equipment and/or supervise outside contractors performing these tasks
• Testing repaired equipment to verify qualified status
• Ensuring a complete stock of backup instruments, spare parts, calibration equipment, other supplies.
• Expert on instrumentation: liaison to management/inspectors
• Write protocols for in-house calibrations/qualifications
• Analyze/suggest equipment upgrades and software
• Study industry guidelines and perform Change Controls to bring Orano Med SOPs into alignment (FDA, USP/EP, ICH, PDA, etc.)
• Oversee investigations to resolve deviations/OOS/recalls/complaints/FMEAs related to equipment.

All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher level position.

Experience:
• BA/BS in a technical field (preferred)
• 2+ y instrumentation, including 1+ y in pharmaceuticals
• Cleanrooms, aseptic technique
• CQV, QMS, cGMP
• FDA regulations, compendial guidelines
• Safety awareness/practices
• Excellent technical skills, troubleshooting
• Ability to meet same-day deadlines
• Attention to detail