Principal/Sr. Principal Engineer, Automation Engineering, Controls System Hardware - Lilly Medicine Foundry

The Principal/Sr. Principal Engineer is also responsible for the productivity and mentorship of the other Engineers on the team to ensure that reliable and compliant control applications and systems are used in manufacturing at Foundry. As a key technical expert, the role collaborates with partners within the process control organization and across functional disciplines to support the process control technical agenda, business plan priorities, and compliance objectives.

Key Objectives/Deliverables

• Lead site operation support, capital project execution, and commissioning & qualification.
• Translate technical concepts for executive audiences and/or non-technical stakeholders.
• Deep expertise working with DeltaV Distributed Control System and Batch Process Automation.
• Deep expertise working with Rockwell Allen-Bradley PLCs and FactoryTalk View.
• Expertise working with DeltaV control panels, DeltaV Remote I/O panels, and Rockwell I/O.
• Perform automation engineering activities including design, development, and commissioning of Process Automation projects using DeltaV DCS, including tuning and troubleshooting of control loops.
• Thorough understanding of various process control communication protocols.
• Develop and implement the Automation Engineering Project Plan.
• Define strategies for periodic and corrective maintenance of instruments and control hardware.
• Provide technical leadership in leading projects from concept through Commissioning and Qualification.
• Resolve complex technical challenges with instrument and control system hardware.
• Technically lead and oversee the work of Site Area Leads and System Integrators.
• Develop and review Functional Requirements, Design Specifications, and Test Specifications.
• Thorough understanding of 21 CFR Part 11 and GMP processes.
• Develop and utilize Master Maintenance Plans.
• Lead/participate in design reviews and site system hardware reviews and attend equipment FATs.
• Provide periodic status updates to Leadership and Project Management.
• Implement and support electronic systems, such as plant historians, used to capture process automation-related production data.
• Maintain the validated state of site control system hardware in line with Lilly quality standards, including development and execution of validation strategies and associated documentation.
• Promote the use of automation to improve productivity, operational efficiency, and compliance.
• Develop a network of corporate contacts and leverage corporate expertise when needed.

Organizational Capability

• In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.
• Mentor the process control team to strengthen technical capabilities and adopt best practices to enhance system reliability and business continuity.
• Be a fully active member of the flow leadership in running the plant, including participation on technical sub-teams.

Basic Requirements

• Minimum B.S. in Engineering or related degree.
• Minimum of 5 years (Principal Engineer level) and minimum of 8+ years' experience (Senior Principal level) working in Biopharma Automation Engineering, preferably in major pharmaceutical manufacturing.
• Experience working in a highly automated facility using DeltaV DCS, Rockwell Allen-Bradley PLCs, Veeva, PI, and/or BMS Warehouse Monitoring from design through startup.
• Knowledge of GMP, regulatory requirements, and computer system validation.
• Available to participate in a rotational on-call schedule.

Preferred Requirements

• Demonstrated initiative, good planning and organizational skills, ability to prioritize tasks, and commitment to task completion and timelines.
• Hands-on experience working directly with automation control panel hardware and wiring.
• Keen technical curiosity and demonstrated strong problem-solving skills and a desire for continuous improvement.
• Demonstrated ability to influence peers and business partners and influence without authority.
• Good written and verbal communication skills for both technical and non-technical audiences.
• Experience in clinical-stage manufacturing with flexible, multi-product capabilities is preferred.