Sr Automation Controls Engineer - Indianapolis IN

Military Spouse Corporate Career Network•Indianapolis, IN

1d•Onsite

About The Position

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.

Requirements

Minimum 7 years' experience in automation/control engineering, ideally within the pharmaceutical or a regulated manufacturing industry.
BS degree in Electrical, Mechanical, Automation, or related Engineering field required.
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.
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 periods of time while performing duties.
Must be willing to wear personal protective equipment (PPE) as required.
Must be comfortable working with radioactive materials.
This is a position that requires working in a laboratory environment.
Protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Nice To Haves

Experience in cGMP Biopharmaceutical, Radiopharmaceutical, or Medical Device environment equipment engineering design, development, and validation is preferred.
MS or advanced degree preferred.
Experience with data historian systems and IT infrastructure preferred.

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.