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 f

Technical Expertise Provide technical expertise in bioburden reduction methods, including aseptic techniques, cleaning, and disinfection practices. Be a subject matter expert in sterility assurance in interactions with regulatory bodies (such as the FDA), notified bodies, and customers. Develop responses to microbiology and sterilization related requests and audit finding

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 Re

Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed. Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records. Collect data for process qualification and implementation. Owning or supporting investigations relat