Senior Process Engineer - Indianapolis, IN

Senior Process Engineer - Indianapolis, IN

Attention Military Affiliated Job Seekers - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please follow the next steps. This role is "On-Site" at the location detailed in the job post.

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Job Responsibilities

The Senior Process Engineer will manage engineering support activities for production operations including management and execution of maintenance and calibration activities. The Senior Process Engineer will provide technical expertise to support the operation and maintenance of all process equipment. Further, the Senior Process Engineer will implement improvement projects to the process equipment including design, execution and hand-over within cost, time schedule, quality and functionality specification.

• Manage and execute new asset installation and configuration
• Manage investigation and troubleshooting efforts in case of equipment issues or failures
• Maintain asset inventory within CMMS
• Maintain calibration, preventive maintenance, and corrective maintenance programs
• Develop and maintain spare parts requirements for process equipment
• Develop, revise, and maintain technical documents for process equipment and GMP risk assessments.
• Interpret P&IDs, equipment/system layouts, wiring diagrams and specifications and manage revisions.
• Own and drive process equipment and procedures deviations, root cause analysis investigations, and CAPAs.
• Reviews equipment and engineering systems to support data collection, root cause analysis investigations, and trend investigations.
• Lead continuous improvement efforts to increase asset reliability including asset modifications.
• Coordinate and execute of assigned projects.
• Support commissioning, qualification, and validation activities when applicable
• Provide technical support during Startup, PQ and validation activities
• Support change requests/change control as needed
• Support internal and external audits

Education and Experience

·BS in Engineering discipline and 5+ years of hands-on experience leading and executing plant maintenance and calibration activities in a GMP manufacturing facility.

·Or AAS in Engineering discipline and 10+ years of hands-on experience leading and executing plant maintenance and calibration activities in a GMP manufacturing facility.

Skills and Qualifications

• Experience in the GMP Pharmaceutical or Medical Device industry is required
• Experience in pharmaceutical aseptic manufacturing is preferred
• Experience with isolators is preferred
• Basic knowledge of Environmental Monitoring, Building Automation, and CMMS systems and architecture is required.
• Vendor management experience is preferred
• Experience managing projects is preferred
• Must be able to adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements. (FDA, USP, OSHA, etc.)
• Proficiency with MS Office Suite
• Working knowledge of electrical, automation systems and robotics
• Must be willing to work around radioactive materials.
• Familiarity with PLC control systems and instrumentation bus technologies.
• Must be flexible to work weekends, and holidays as required

Physical Demands

Ability to climb ladders and lift up to 50 lbs. This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials. Work Environment The noise level in the work environment is usually moderate.

Compensation Overview: Indianapolis - RayzeBio - IN: $96,148 - $116,508