Process Engineer

Summary Of Position

The Process Engineer – Cyclotron provides technical discipline and leadership required to maintain, plan and implement robust and capable cyclotron derived API manufacturing processes, as well as upstream process activities at the Noblesville, IN facility.

This role will be responsible for performing the following: identifying and implementing improvements and new technologies to processes to increase productivity, improve quality and reduce costs; leading API process equipment troubleshooting efforts along with coordinating other support groups to return equipment to service; serving as a Subject Matter Expert (SME) and leading API product/process failure investigations, implementing corrective actions, and preparing sound scientific reports;

authoring and providing technical support for developing new processes and equipment documents including URS (user requirements specifications), DOE’s (design of experiments), and validation documents; authors and/or reviews change control submissions to ensure the validated status of equipment is maintained; and reviewing, monitoring and trending operating data, consistently applying operational excellence and continuous improvement skills / tools in evaluating the data, and issuing related reports and recommendations for maintaining and improving process reliability.
Technical requirements will also include a thorough and demonstrable knowledge of cGMP’s (Current Good Manufacturing Practice) and applicable industry standards. The Process Engineer will report directly to the Director of Operations and be responsible for working in collaboration with other manufacturing production, maintenance, and engineering team members, this role will also readily coordinate with members from the R&D, project engineering, quality assurance, quality control, validation, procurement, commercial sales and marketing, and distribution teams within Curium.

This position supports production in a 24-hour manufacturing facility and may require evenings, nights, weekends, and some holidays with occasional overtime.

• Leading process troubleshooting and remediation efforts.
• Maintain control of API process changes including change control management and documentation.
• Providing adequate and documented monitoring of the department API processes through trending, run reports, and tracking through SPC (Statistical Process Control) or other tools.
• 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 cost reduction initiatives.
• Assist in the development and maintenance of process equipment, procedures, batch records, and training materials.
• Ability to influence proper operating procedures during the manufacture of API pharmaceuticals (Compliance with regulations, GMP behaviors / techniques, etc.)
• Identifying capital needs for the department processes.
• Support annual capacity analysis.
• Facilitate technical transfers from R&D.
• Provides technical expertise and support to project management teams during project life cycles.
• Executes low to medium complexity projects, including:
  • Purchasing equipment to support API processes or manufacturing areas.
  • Composing associated capital request and processing financial information.
  • Capital funding for outside services as it relates to manufacturing (equipment upgrades, facility improvements, risk assessments, validation services, process engineering assistance).
• 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 Degree in Chemical Engineering or related field required (other engineering disciplines may be considered based on professional experience.)
• Three years or more of experience working as an engineer in an FDA regulated, GMP facility.
• Three years or more of manufacturing experience; preferably in the manufacture of API and/or finished pharmaceuticals.
• Experience preferred in the following areas:
  Ion-exchange chromatograph,…