About the role Hiring immediately. Daxor Corporation makes blood volume analysis technology that hospitals use to measure a patient's blood volume directly, guiding treatment in heart failure, critical care, and surgery. At our Oak Ridge facility we manufacture the iodine-131-labeled albumin injectables used in these tests. We're hiring a cleanroom production technician to make these sterile products under FDA cGMP, working in ISO 5 (Class 100) laminar flow hoods and following a written batch record. If you've worked in sterile compounding, nuclear pharmacy, pharmaceutical manufacturing, or as a radiological worker and want to learn the other half, we want to hear from you. We train on radiation safety and on our specific processes. What you'll do Manufacture sterile injectable batches per approved batch records in an ISO 5 cleanroom Perform chemical purification and aseptic filling in ISO 5 laminar flow hoods Perform in-process sampling and support release testing Clean and sanitize cleanroom areas and hoods Perform viable and nonviable environmental monitoring Complete gowning qualifications and participate in aseptic process simulations (media fills) Execute
IQ/OQ/PQ
qualification protocols under QA and engineering direction Run routine equipment checks and calibration verifications per SOP Document all work accurately and in real time (Good Documentation Practices) Follow ALARA radiation safety: dosimetry, contamination surveys, and radioactive waste handling under our Tennessee license What you need Associate's degree in a chemical, physical, biological, or engineering science, or equivalent experience (military, pharmacy, or manufacturing) 1+ year in cGMP pharmaceutical or biologics manufacturing, cleanroom operations, sterile/USP 797 compounding, or nuclear pharmacy Comfort following written procedures exactly and documenting everything Able to work fully gowned for extended periods, stand for long stretches, and lift up to 40 lbs Willingness to participate in radiation dosimetry and bioassay monitoring Authorized to work in the US (we are unable to sponsor visas) Preferred Radiological worker training or experience handling radioactive materials Aseptic processing experience, including media fills and gowning qualification Wet chemistry lab experience Experience with IQ/OQ/PQ or validation protocols
Pay:
$65,000.00 - $85,000.00 per year
Benefits:
401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance
Education:
Associate (Required)
Experience:
ISO-classified cleanroom laminar flow hoods: 1 year (Preferred) FDA cGMP or GLP environment: 1 year (Preferred) radiological worker: 1 year (Preferred)