Senior Process Engineer

Senior Process Engineer

The Senior Process Engineer – Strontium provides technical discipline and leadership required to maintain, plan and implement robust and capable cyclotron and 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; 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; and providing operations support to both the Cyclotron and Strontium Chemistry departments as needed.

Work Schedule:

M - F 8am - 5pm, unless business needs dictate otherwise. This position supports production in a 24-hour manufacturing facility and may require evenings, nights, weekends, and some holidays with occasional overtime.

Essential Functions 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.). Leading process troubleshooting and remediation efforts for both the cyclotron and strontium chemistry departments. Maintain control of API process changes including change control management and documentation. Providing adequate and documented monitoring of the department API processes through trending, running 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.)

Leads and plans strontium chemistry operations as needed. Executes and improves IQOQs, calibration procedures, and protocols for cyclotron and chemistry equipment. Conducts troubleshooting, maintenance, and improvement initiatives for hot cells, tele-manipulators, and production equipment. Leads and/or assists with cyclotron engineering initiatives, such as troubleshooting and maintenance. Provides targetry support (carrier construction, testing, loading; target construction, testing, filling) as needed. Provides cyclotron operations support as needed to maintain continuous production.

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 requests 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). BMS upgrades and programming updates

Requirements Bachelor's degree in chemical engineering or related field required (other engineering disciplines may be considered based on professional experience.) 5+ years of experience working as an engineer in an FDA regulated, GMP facility 2+ years of manufacturing experience; preferably in the manufacturing of API and/or finished pharmaceuticals. 3+ years of experience working with particle accelerators, including operation, troubleshooting and maintenance.

Experience preferred in the following areas:
Ion-exchange chromatograph;
Lab View;
Electroplating; small (volume), high value API production batches. Verifiable knowledge of and experience in application of cGMP's, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives. Experience in applied knowledge of necessary behaviors and techniques associated with pharmaceutical production. Knowledge of current industry practices and…