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.

Key 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).

Qualifications

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.

Important Notice:

In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

"Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1."

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$105,000 - $154,000

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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