Sr Automation Controls Engineer - Indianapolis

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, unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

The Senior Automation/Controls Engineer is an integral part of bringing Rayze Bio’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).

• 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.

Auto req 485278

Minimum Education Required Bachelors

• 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.

• Expert in automation system architecture, design, integration, and troubleshooting.
• Strong knowledge of Rockwell/Siemens PLC programming, SCADA, and HMI development.
• Strong knowledge of Cognex vision systems and Robotics.
• Strong troubleshooting experience on process equipment, including but not limited to:
  Field instrumentation Control panels VFDs (Variable Frequency Drives).

• Deep understanding of GMP, validation, regulatory standards, and industry best practices.
• Proven leadership with the ability to lead complex technical projects and mentor team members.
• Commitment to continuous improvement and operational excellence.
• Excellent professional ethics, integrity, and ability to maintain confidential information.
• Organized and detail-oriented.
• Strong time management and organizational skills.
• Strong interpersonal communication skills.
• Motivated, adaptable, accountable, and collaborative. Able to support a manufacturing environment under pressure.

Standard office environment coupled with GMP production and facility environments.

Responsibilities also include the ability to lift 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.

Ability to sit or stand for long…