Summary of Position

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.
• Trains employees on cyclotron operations, strontium chemistry, and other technical production tasks as needed.
• 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 lifecycles.
• 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; LabView; 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 technologies.
• Proven experience in supporting and optimizing processes and equipment, as well as leading small teams, groups or efforts relating to those activities.
• Experience applying formal Root Cause Analysis and problem-solving methodologies
• Experience using SPC and other Operational Excellence methodologies; Lean and/or Six Sigma certification preferred
• Experience with radioactive isotopes and radiation safety programs is required.
• Must achieve and maintain Class 1 radiation worker status.

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.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.