Senior Process Engineer

The Senior 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 Senior Process Engineer will work collaboratively in a cross-functional organization with R&D, Project Management Organization, Quality Assurance, Quality Control, Validation, and Manufacturing.

The ideal candidate would have experience in pharmaceuticals, biologics, GMP manufacturing, or within highly regulated industries. The ideal candidate would also have knowledge in automated visual inspection and labeling of vials.

Work Schedule:

Monday-Friday, 8:00a.m.

-5:00p.m. Hours may be adjusted based on business needs.

Job description:

The Senior 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 Senior Process Engineer will work collaboratively in a cross-functional organization with R&D, Project Management Organization, Quality Assurance, Quality Control, Validation, and Manufacturing.

The ideal candidate would have experience in pharmaceuticals, biologics, GMP manufacturing, or within highly regulated industries. The ideal candidate would also have knowledge in automated visual inspection and labeling of vials.

Work Schedule:

Monday-Friday, 8:00a.m.

-5:00p.m. Hours may be adjusted based on business needs.

• Lead process improvement, reliability improvements, troubleshooting, and remediation efforts related to manufacturing processes or equipment.
• Support cross-functional projects and project teams through process evaluation, design, and implementation of robust processes for new products within existing or new manufacturing equipment.
• Write technical documentation, including protocols and reports for equipment and process improvements.
• Author deviations to investigate the root cause of a failure and propose corrective and preventive actions to eliminate the root cause.
• Support product launch activities and implementation of new manufacturing lines.
• Work collaboratively to quickly move projects from scoping to implementation.
• Partner with Quality to ensure implementation of cGMP practices.
• Provide input into forecasts for project-related costs and track project tasks against milestone goals.
• Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.

• Bachelor degree in Engineering. Mechanical Engineering is preferred; chemical, biochemical, biotechnology, or other engineering disciplines will be considered based on professional experience.
• Five or more years of relevant experience in cGMP manufacturing environments.
• Significant experience in optimization of processes, including establishment of process KPIs.
• Experience in automated visual inspection or pharmaceutical packaging is desired; experience in other regulated industries, such as medical devices or food processing, may also be considered.
• Verifiable knowledge of and…