Automation (Controls) Engineer-Device Manufacturing

Role Summary

Automation (Controls) Engineer-Device Manufacturing at Lilly. Responsible for design, delivery, qualification/validation of device assembly equipment with a focus on automated control and electrical systems within the Indy Device Manufacturing (IDM) organization.

Responsibilities

• Automated Control Systems Expertise: PLCs, motion, HMIs, vision systems, robots, safety systems.
• Industrial Machinery Electrical Systems Knowledge: NFPA 79/UL508A standards, industrial wiring and components, power distribution, control wiring, electrical safety.
• Computer System Validation Expertise: Data integrity, document deliverables, qualification/validation and security methods for automated controls systems.
• Equipment Integration: Design, qualification/validation and delivery compliance for automated control and electrical systems into local receiving site systems standards (SCADA, MES, automated material delivery).
• Process/Product Improvements: Project planning, protocol development, testing coordination, data documentation, Source Code Reviews (SCR), systems management activities (Backups, Installations, Restores), maintaining Source Code (SC)/Configuration Management Systems (CMS), and associated documentation and reports.
• Assessments and Technical Recommendations: Ensure processes, RFP, design, facilities, equipment, and systems are compliant, capable, controlled, and validated.
• Generate and manage user requirements for the equipment’s automated control and electrical systems.
• Conduct detailed review sessions with OEMs and project teams, resolving questions and removing barriers to progress.
• Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.
• Technical Stewardship: Support projects to improve assembly equipment design.
• Tool and Process Validations: Create, execute, and coordinate validation activities with Contract Manufacturers.
• Risk Mitigation: Define and mitigate technical and patient risks using FMEA.
• Technology Re-use: Maximize re-use of leveraged technology from prior projects.
• Engineering Studies: Characterize unit operations, set operating conditions, develop and execute studies.
• Testing Development: Ensure testing aligns with risk levels.
• Documentation: Document research and investigations as technical reports.
• Commercialization Projects: Participate in teams focusing on manufacturing readiness for new devices.

Qualifications

• Minimum: BS in Engineering or engineering-related field, or Associate's degree plus equivalent work experience.
• Minimum 2 years of Industrial Controls experience.
• Experience in programming and/or maintaining automated control systems (PLCs, HMIs, vision robots), preferably in discrete manufacturing.
• Experience in design and/or maintaining industrial machinery electrical systems.
• Experience designing, maintaining, or delivering automated equipment.

Additional Preferences

• Medical devices experience preferred.
• SCADA, MES, data collection, or IT experience.
• Computer System Validation experience preferred.
• Rockwell control system experience.
• Cognex Vision system experience.
• Expertise with industrial networks.
• DOE and statistical methods in engineering.
• Large capital project delivery and sub-project management.
• Engineering in regulated pharmaceutical environments (cGMPs/Commissioning and Qualification).
• Experience in programming control systems for high-speed assembly lines.
• Expertise in automation networks, vision systems for part inspection, debugging of assembly lines.

Skills

• High initiative, ownership, and accountability
• Strong communication, teamwork, and networking
• Solid technical writing
• Organization and prioritization of multiple tasks
• Attention to detail
• Problem-solving
• Ability to work independently and in teams

Education

• BS in Engineering or Engineering-related field; or Associate's degree with equivalent experience

Additional Requirements

• Ability to travel 25% on average with peak times over 50% for several months