Principal Engineer CSV and Data Integrity

Eli Lilly and Company; Indianapolis (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled Engineer for Computer System Validation and Data Integrity. This role is pivotal in leading corporate engineering efforts to enhance data integrity practices across manufacturing sites. The ideal candidate will possess a strong background in process automation and regulatory compliance, ensuring that systems meet stringent quality standards. You will collaborate with diverse teams, innovate verification processes, and guide automation quality initiatives. This position offers an opportunity to make a significant impact in a global healthcare leader, contributing to the development of life-changing medicines while ensuring operational excellence.

Qualifications

• 3+ years of experience in process automation engineering is required.
• Strong understanding of data integrity and validation practices.

Responsibilities

• Lead corporate engineering for Data Integrity programs and assessments.
• Support automation teams in capital projects and validation strategies.

Skills

Process Automation Engineering

Data Integrity

Commissioning and Qualification (C&Q)

Systems Integration

Regulatory Knowledge

Collaboration

Education

Bachelor of Science Degree in Engineering

Bachelor's in Chemical, Mechanical, Electrical, or Computer Engineering

Tools

Rockwell Automation

Emerson DeltaV

Foxboro

Microsoft Operating Systems

Job description

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.

Organization Overview:

Digital Manufacturing Engineering (DME) is part of the Corporate Engineering Tech Center (ETC). The ETC is a technical resource for training, standards, project implementation, and the center of engineering excellence for the corporation, providing deeply technical resources to solve the most intractable technical problems in manufacturing. DME provides OT data integration solutions, engineering data standardization/ownership, digital manufacturing solutions, and leads OT Data Integrity and Cyber Security initiatives and standards globally for Lilly Manufacturing. Our team focuses on connecting our facilities (securely) and leveraging the data from those facilities to deliver digital manufacturing solutions to improve manufacturing productivity, data integrity / compliance, quality, and operational excellence. Digital Manufacturing Technologies include digital twins, computational modeling, edge/IoT, and analytics solutions.

Position Description and Responsibilities:

The Engineer – Computer System Validation and Data Integrity is an Engineering role will be the corporate engineering Computer System Validation/Data Integrity lead and will support Lilly facilities globally working closely and collaboratively with MQ-Tech@Lilly and Global Quality. The position requires a high learning agility and experience in one or more process automation systems with a strong focus on data, systems integration, Commissioning and Qualification (C&Q) methods, architecture, and supporting automation platforms.

This role will require a strong understanding of automation/computer system validation practices and industry/regulatory knowledge in Data Integrity and Lilly Quality Systems. The role will also support automation teams' delivery in capital projects and provide guidance on automation/computer system testing and Data Integrity Assessments.

Key Objectives/Deliverables:

• Work safely and continuously look for improvements to both people and equipment safety.
• Provide corporate engineering leadership to Data Integrity programs, new asset DI assessments, and develop best practices and standards to support manufacturing and major capital project delivery.
• Provide Process Automation reviews and influence Global Quality Procedures that impact computer systems and automation platforms.
• Develop and lead a community of practice for our manufacturing sites for Data Integrity and CSV programs.
• Develop templates and standards for Verification (formerly known as Commissioning and Qualification).
• Innovation - Evaluate new technologies for Verification such as electronic testing systems.
• Support Major Capital Projects in setting up Computer System Validation strategies for automation systems.
• Provide quality oversight to central solutions and libraries.
• Own Global Engineering Best Practices for Manufacturing on Data Integrity Information Classification.
• Lead / Facilitate Automation Quality Team.

Basic Qualifications:

• Bachelor of Science Degree in engineering or a related science field.
• 3+ years of experience in process automation engineering supporting a manufacturing site, with demonstrated work and/or training in one or more process automation platforms.
• Experience working in a regulated industry.

Additional Skills/Preferences:

• B.S. preferably in Chemical, Mechanical, Electrical, or Computer Engineering.
• Experience in pharma or GMP industry.
• Experience in commissioning and qualification.
• Experience working with validated systems.
• Expertise in Lilly’s preferred platforms, including Rockwell Automation, Emerson DeltaV, Foxboro, and Microsoft Operating Systems.
• Ability to work well with different cultures and engineering disciplines internationally.
• Knowledge in Historians, and IT platforms such as servers, and workstations.

Additional Information:

• Monday through Friday Day Shift of 7:30am-4:30pm with some allowance for flex time.
• This is NOT a remote position and requires onsite presence.
• Limited Domestic and International travel required (less than 10%).