Life at BMS
At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/
The Senior Automation/Controls Engineer is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to engineering leadership and be primarily responsible for automation engineering work supporting clinical and commercial manufacturing objectives at the Indianapolis site(s).
You will design, develop, improve, manage, and support automation and control systems with novel Radiopharmaceutical technologies including, but not limited to, custom Hot Cells, formulation and filling lines, environmental monitoring systems, and building automation systems. Additional responsibilities will include working with engineering firms and specialty equipment manufacturers to achieve our clinical and commercial manufacturing objectives.
Job Responsibilities
Accountable for continuous operation and maintenance of automation and control systems for Radiopharmaceutical Clinical and Commercial manufacturing.
Lead development, deployment, and lifecycle management of automation and control systems for radiopharmaceutical manufacturing processes and equipment.
Support GMP manufacturing operations by leading and/or contributing to deviation investigations, CAPA development and execution, and change control activities, with on-call responsibility during evenings, weekends, and other non-standard business hours.
Architect and implement robust PLC, HMI, SCADA, and related automation platforms to enable facility expansions and commercialization efforts.
Oversee integration of automated systems with existing production lines and corporate business systems, ensuring regulatory and GMP compliance.
Optimize automation system performance, troubleshoot complex issues, and develop strategies for preventative and predictive maintenance.
Provide technical leadership and expertise in commissioning, validation, and upgrades of process automation equipment and instrumentation.
Collaborate extensively with Engineering, Production, and Quality teams to define requirements and deliver high-quality automation solutions.
Manage relationships and direct activities with external vendors, partners, and contractors for system selection, installation, and validation.
Author, review, and approve detailed technical documentation, including SOPs, system specifications, and validation protocols.
Champion compliance with EHS, Radiation Safety, and all relevant regulatory requirements, fostering a culture of safety and quality.
Mentor and train junior engineers and staff on automation technologies and best practices.
Leverage AI tools to enhance individual productivity and quality of work.
Support business needs through up to 15% travel, as required.
Education and Experience
Minimum 7 years' experience in automation/control engineering, ideally within the pharmaceutical or a regulated manufacturing industry.
Experience in cGMP Biopharmaceutical, Radiopharmaceutical, or Medical Device environment equipment engineering design, development, and validation is preferred.
BS degree in Electrical, Mechanical, Automation, or related Engineering field required.
MS or advanced degree preferred.
Skills
Expert in automation system architecture, design, integration, and troubleshooting.
Strong knowledge of…