Manufacturing Technician

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve:
An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

The role of a Manufacturing Technician, located at our Noblesville, Indiana facility, is to perform all tasks associated with formulation, preparation, assembling, and packaging of components, according to cGMP Guidelines to meet production demands. The Manufacturing Technician will have knowledge of the manufacturing process and serve as one of several technicians while coordinating work within the standard operating procedures (SOP’s).

Work Schedule:

Night Shift, Friday night/Saturday morning through Tuesday night/Wednesday morning. 6:00pm - 2:30am. Schedule could be adjusted. Ability to work overtime when necessary. Will need to train for 3-6 months on Day shift and then will switch to the night shift.

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Ensure strict adherence to quality, safety, regulatory, and written procedures in the manufacture of products in accordance with OSHA and CFR (cGMP) guidelines.
• Handling of radioactive materials with strict adherence to ALARA principles and dosimetry monitoring.
• Aseptic technique under radioactive constraints – clean room and hot cell / isolator environments (remote tools, lead glass visibility, integrated gloves and/or tele manipulators).
• Ensure vigilance to the production schedule to meet customer demands and reduce overtime (ensure most effective and efficient use of personnel, materials, and time).
• Execute aseptic manufacturing, in-process controls, and documentation activities in accordance with cGMP requirements and within critical time frames dictated by the radioactive decay of short-half-life isotopes.
• Takes ownership and is an active member with continuous improvement activities including: reliability team meetings, root cause analysis, SOP and Batch record improvements, Kaizen events, and Customer Complaints.
• Ensure the maintenance and cleanliness of department, premises, and equipment.
• Perform Batch Record calculations (including complex calculations) and maintain all documentation according to SOPs and cGMP Guidelines. Review documentation, make corrections, and sign off as required by SOPs and cGMP Guidelines.
• Monitor product quality to ensure compliance with standards and specifications.
• Participate and perform effectively in a team environment and interact with multiple departments to ensure the operational success of the team.
• Follow all written procedures and verbal instructions and communicate effectively, both written and verbally.
• Inspect in-process and finished products for quality and adherence to customer specifications.
• Ability to identify and verify appropriate materials, area conditions, process for production and address any abnormalities in the process, with materials or in area conditions in collaboration with Quality and leadership.
• Take full ownership and accountability of equipment, process, and area assigned to or related to production process.
• Use logical methods to solve difficult problems with effective solutions and is able to make sound decisions in a timely manner, sometimes with incomplete information,…