Process Engineer

Process Engineer

Date:
Feb 20, 2026

Location:

Noblesville, IN, 46060

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 Process Engineer will be a key contributor in a dynamic manufacturing organization at the Noblesville, Indiana facility. The role will support fast paced manufacturing of Curium's radiopharmaceutical therapeutic sterile drug products.

The role will develop solutions and implement new technology to improve the reliability and quality of the manufacturing process through writing and implementing change controls and corrective and preventative actions. Additionally, the role will troubleshoot equipment issues. The Process Engineer will work collaboratively in a cross-functional organization with R&D, Project Management Organization, Quality Assurance, Quality Control, Validation, and Manufacturing.

Friday through Tuesday 6pm - 3am. Hours could be adjusted. This position supports production in a manufacturing facility and will require holidays, weekends, and overtime.

• Leading process reliability, troubleshooting, remediation, and improvement efforts related to manufacturing processes or equipment.
• Author deviations to investigate root cause of failure and propose corrective and preventative actions to eliminate root cause.
• Identify and support departmental change initiatives for continual process improvement, specifically around Operational Excellence, 6-Sigma and Lean Manufacturing applications. Will serve as a departmental driver for reliability initiatives.
• Implement process and equipment improvements through change controls and corrective and preventative actions.
• Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.
• Providing adequate and documented monitoring of the department processes through trending, batch run reports and tracking through SPC (Statistical Process Control) or other tools.
• Ability to influence proper operating procedures during manufacturing (Compliance with regulations, GMP behaviors / techniques, etc.)
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor's Degree in Engineering or related field required (Preferred Mechanical, but Chemical, Biochemical, Biotech, or other engineering disciplines will be considered based on professional experience).
• 3 years or more of experience working as an engineer in an FDA regulated, GMP facility. Preferred experience in pharmaceutical fill/finish manufacturing.
• Willing to consider other highly regulated experience (i.e. PSM, high hazard, NRC)
• Experience leading formal Root Cause Analysis and problem-solving methodologies.
• Verifiable knowledge of and experience in application of cGMP's, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.
• Strong oral and written communication skills with proven ability to communicate effectively at all levels in high pressure environments.
• Agile approach and willingness to learn new things - ability to work "on the fly" in a dynamic setting.
• Knowledge of aseptic technique,…