Orano - Brownsburg, IN
posted 16 days ago
- Intern
Brownsburg, IN
Utilities
About the position
The Intern - Radiopharmaceutical Manufacturing will participate in the establishment of ATLab Indianapolis as a new commercial-scale manufacturing facility for therapeutic radiopharmaceuticals. During Summer 2024, the facility will be concluding construction and qualification, so the Intern should focus efforts on: safety and occupational training, completing an assigned project, helping with basic tasks, growing in technical understanding, developing workplace skills, and building a professional network.
Responsibilities
- Read and follow all assigned relevant SOPs.
- Participate in reading/on-the-job training in radiation safety, hazardous materials, and occupational safety.
- Assist with submissions and compliance for RAM license and environmental compliance.
- Observe/assist with qualification of spaces: IQ/OQ/PQ of cleanrooms and aseptic spaces.
- Assist with qualification (IQ/OQ/PQ) of new equipment and instrumentation.
- Observe and understand the function of all instrumentation and the chemistry behind production of Pb-212 and radiolabeled final drug product.
- Assist with implementation of new software: inventory management, chemical inventory, eBR, LIMS, dose ordering, shipping software, etc.
- Assist with inventory management of consumable supplies, including planning, purchasing, inspecting, and accepting incoming supplies.
- Assist with design and implementation of shipping equipment and procedures.
- Embody and promote a culture of quality and continuous improvement.
- Adhere to all applicable procedures, cGMP, company policies, and any other quality or regulatory requirements.
- Learn about and gain comfort with cGMP and QMS.
- Assist with preparing and reviewing documents: SOPs, vendor qualification forms, material acceptance forms, instrument qualification forms, etc.
- Identify and complete a project with reasonable scope during the period of the internship.
