Process Engineer

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.

Work Schedule: 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, regulatory requirements, and validation activities needed for manufacturing parenteral products preferred.
• Experience in applied knowledge of necessary behaviors and techniques associated with pharmaceutical production preferred.
• Experience with radioactive isotopes and radiation safety programs is preferred.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.