Cleanroom Facility Specialist

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This range is provided by Isotopia Molecular Imaging ltd. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$65,000.00/yr - $77,000.00/yr

Cleanroom Facility Specialist

Isotopia is a global biotech company manufacturing key ingredients for pharmaceutical cancer drugs. At our U.S. headquarters in Indianapolis, we are located next door to our key customers, delivering our products just in time, each day, every day. We are seeking a highly motivated and detail-oriented Cleanroom Facility Specialist to join our team. The Cleanroom Facility Specialist will play a critical role in maintaining the cleanliness, environmental control, safety, and regulatory compliance of cleanroom facilities supporting radiopharmaceutical manufacturing operations.

This role is essential to ensuring aseptic conditions, radiation safety, and compliance with cGMP, NRC, DOT, and other applicable regulatory requirements for the production and distribution of high-quality radiopharmaceutical products. This position requires strong attention to detail, excellent organizational skills, and a demonstrated commitment to cleanroom discipline, contamination control, and radiation safety.

• Maintain day‑to‑day readiness of cleanroom suites, controlled manufacturing areas, and support spaces by ensuring compliance with approved Standard Operating Procedures (SOPs) and regulatory expectations
• Perform routine cleaning, sanitization, and disinfection of cleanroom areas in accordance with validated cleaning procedures and established cleaning frequencies
• Ensure proper cleanroom gowning practices are followed and that all gowning materials are adequately stocked and available
• Maintain aseptic conditions and proper cleanroom behaviors to minimize particulate and microbial contamination risks
• Clean, sanitize, and maintain cleanroom equipment and ancillary tools to ensure fitness for use and contamination control

• Execute routine and event‑driven environmental monitoring activities, including viable (microbial) and non‑viable (particle) monitoring, surface sampling, and air sampling, in accordance with SOPs
• Perform daily wipe tests and radiation surveys in manufacturing suites and quality control laboratories when radioactive materials are handled
• Collect environmental and microbial samples, perform in‑process monitoring during manufacturing activities, and ensure proper sample handling and documentation
• Log and trend cleanroom environmental parameters, including temperature, humidity, air quality, airflow, and pressure differentials
• Maintain and support inspection and replacement schedules for cleanroom filtration and HVAC systems

• Perform removal, segregation, and disposal of dry active radioactive waste from manufacturing and cleanroom areas in compliance with NRC license conditions and site radiation safety procedures
• Conduct radiation and contamination surveys of waste materials to determine appropriate decay‑in‑storage or disposal pathways
• Maintain accurate inventories and records of radioactive waste held for decay

• Perform daily functionality checks and operational verification of radiation detection and monitoring equipment, including survey meters, area monitors, personal electronic dosimeters, and hand‑and‑foot contamination monitors
• Ensure monitoring equipment remains operational, properly stored, and reported for calibration or maintenance when required

• Assist in the preparation, packaging, labeling, and release of radioactive material (RAM) packages in accordance with NRC license requirements, DOT regulations (49 CFR), and applicable IATA standards, as required
• Verify package integrity, radiation and contamination survey results, shipping documentation, and chain‑of‑custody requirements prior to shipment
• Deliver compliant RAM packages to customers or authorized…