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Description

Job Title: 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.

Responsibilities:

Cleanroom Operations:

·       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.

Environmental Monitoring:

·       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.

Radiation Safety & Waste Handling:

·       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.

Radiation Monitoring Equipment:

·       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.

RAM Packaging and Transport (NRC / DOT):

·       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 courier sorting facilities in accordance with approved transport procedures and security requirements.

Documentation, Training, and Compliance:

·       Maintain accurate, contemporaneous records of cleaning activities, environmental monitoring data, radiation surveys, waste handling, and shipping activities in compliance with cGMP and NRC documentation requirements.

·       Generate reports and supporting documentation for internal review, audits, and regulatory inspections.

·       Provide training to cleanroom personnel on cleanroom behaviors, environmental monitoring practices, aseptic techniques, and equipment use.

·       Participate in emergency response training, drills, and incident response activities related to cleanroom operations and radiological events.

Continuous Improvement:

·       Identify opportunities for process improvements, efficiency gains, and best practices related to cleanroom operations, contamination control, and radiation safety.

·       Collaborate with Quality Control, Production, Engineering, and Radiation Safety to support investigations, corrective actions, and continuous improvement initiatives.

Requirements

Education and Skills:

·       High school diploma or equivalent required; technical training or certification in cleanroom   operations, contamination control, radiation safety, or related disciplines preferred.

·       Prior experience working in a cleanroom or controlled manufacturing environment, preferably within pharmaceutical or radiopharmaceutical operations.

·       Strong understanding of aseptic technique, cleanroom behaviors, and contamination control principles.

·       Familiarity with environmental monitoring methods, radiation surveys, and controlled documentation practices.

·       Working knowledge of cGMP requirements and quality systems; familiarity with NRC-regulated radioactive material handling and transport preferred.

·       Strong written and verbal communication skills.

·       Detail-oriented with the ability to follow strict SOPs and regulatory procedures.

·       Ability to work effectively in a team-oriented, cross-functional environment.

·       Proficiency in basic computer applications and electronic documentation systems.

·       Ability to stand for extended periods and perform bending, lifting, and material handling tasks as required.

·       Comfortable working in full cleanroom gowning, including coveralls, gloves, masks, and shoe covers.

·       Willingness and ability to work occasional off-hours or weekends as operational needs require.

This job description is a general outline of responsibilities and qualifications for the Cleanroom Facility Specialist role at Isotopia USA. It is not exhaustive, and additional duties may be assigned based on business needs and priorities.

We offer a competitive salary, a comprehensive benefits package, and opportunities for advancement.
Isotopia is an Equal Opportunity Employer committed to fostering a diverse and inclusive workforce.

Benefits

• 401 K Retirement Program with 5% of Salary Company Contribution
• Individual and Dependent Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Short-term Disability Insurance
• Long-term Disability Insurance