Sr. Principal Engineer - Automation

Eli Lilly and Company • Carolina, PR

5d • $105,000 - $154,000

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Sr. Principal Engineer – Automation is a senior technical leader and subject matter expert for the PR01 manufacturing site. This role is responsible for providing automation advisory, technical leadership, and mentoring across key areas including Automation Lifecycle Management (LCM), System Integration, Capital Projects, Manufacturing and Business Process Improvements, and Compliance with Automation Systems. The ideal candidate brings deep expertise in pharmaceutical automation and a proven ability to influence, lead, and deliver results in a highly regulated environment.

Requirements

• Education Bachelor's degree in Electrical, Computer, Mechanical, or Industrial Engineering — or equivalent.
• Experience 10+ years of technical experience in automation, including project execution and/or operational support.
• Demonstrated experience with Computer Systems Validation (CSV) in regulated environments; GMP operations strongly preferred.
• 5+ years of pharmaceutical manufacturing experience highly recommended.
• Knowledge & Skills Strong working knowledge of cGMP, 21 CFR Part 11, FDA Computer Systems regulations, OSHA, and related compliance frameworks.
• Proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint, Project).
• Proven ability to lead root cause analyses, risk assessments, and complex technical investigations.
• Strong project management, negotiation, and presentation skills.
• Excellent technical writing skills with experience authoring technical reports, risk assessments, and control system reviews.
• Language Requirements Fully bilingual in English and Spanish — written and verbal communication required.

Responsibilities

• Technical Advisory & Mentorship Coach and mentor automation engineers on engineering principles, process control, control system design, problem solving, and project management.
• Serve as the primary subject matter expert for cross-functional teams including Technical Services, Maintenance, Engineering, and Quality.
• Promote consistency in the application of automation engineering principles across the site.
• Identify development needs and create opportunities for knowledge sharing through internal/external training and technical forums.
• Stay current with emerging technology trends, Data Integrity requirements, and Cybersecurity best practices.
• Participate in the selection and performance assessment of technical personnel.
• Technical Leadership – Process & Equipment Provide site-level technical expertise in the design and oversight of control systems and manufacturing processes.
• Own automation metrics; perform quarterly holistic analysis, identify trends, and present findings in Engineering Lead Team or Digital Plant forums.
• Lead complex troubleshooting and investigations related to compliance (Quality/EHS) issues or manufacturing interruptions.
• Oversee alarm strategy exercises, system administrator activities, and risk review exercises impacting site operations.
• Review and approve automation drawings, equipment layouts, control system designs, and Factory Acceptance Tests (FATs).
• Assist in the preparation and execution of commissioning and qualification activities.
• Own the Asset Qualification Monitoring Strategy (AQMs) and Lifecycle Management (LCM) for control systems.
• Manufacturing & Business Process Improvements Lead design and installation of new equipment, including developing scope of work for capital projects and providing technical expertise during design, installation, and validation phases.
• Support functional groups in evaluating and implementing equipment and operational changes, including process hazard impact assessments.
• Drive improvements targeting cycle time, yield, product quality, materials consumption, waste reduction, and process safety.
• Compliance Lead, review, and support event investigations and action plans (Quality, Safety, Environmental, and Process Safety).
• Lead development and implementation of change control documentation and deviation management.
• Ensure compliance with applicable regulatory agencies including FDA, OSHA, EPA, and HSE standards (cGMP, 21 CFR Part 11).

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior