Lab Systems Engineer

Eli Lilly and Company; Lebanon (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Eli Lilly and Company in Lebanon, IN, seeks a Lab CSV and Compliance Analyst to validate laboratory systems and instruments, ensuring data integrity and regulatory compliance across GMP processes.

This role focuses on IQ/OQ/PQ for equipment and software, maintaining validated state, and collaborating with global QA and IT teams to enable compliant lab operations at LP1.

Qualifications

• BS degree in IT/Engineering/CS or related field.
• 5+ years in CSV within a regulated (GMP) environment.
• Authorized to work in the United States full-time; no visa sponsorship.
• Knowledge of GAMP, GMP, and data integrity principles.

Responsibilities

• Validate lab equipment and software (IQ/OQ/PQ) and ensure system qualification.
• Maintain validated state of software-based systems and lab instruments.
• Manage audit trails, workstation security, and equipment integration.
• Support deployment/upgrade of MODA, Empower, NuGenesis, LabVantage CSV needs.
• Collaborate with CSQA, IT, and Global Quality Lab network to enforce standards.
• Support DI/CSV deviations and CAPAs within LP1 labs; coordinate audits/inspections.
• System administration for E3B and provide CSV consulting with vendors.

Skills

Data Integrity

CSV

IT governance

Communication

Problem-solving

Adaptability

Education

Bachelor of Science in IT/Engineering/CS

Tools

MODA

LabVantage

NuGenesis

Empower

WinKQCL

Job description

• Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $3 Billion to create a new state-of-the-art manufacturing site for Drug Substance, in Lebanon, Indiana. The brand-new facility will use a variety of Platforms and have the latest technology for API Manufacturing and Technology.
• This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Lebanon API Manufacturing site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

What You’ll Be Doing

• You will be part of Technology at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Technology at Lilly MQ strives to enable the making of medicine “with safety first and quality always”.
• As a Lab CSV and Compliance Analyst, you will ensure the manufacturing Labs systems (MODA, LabVantage, NuGenesis, Empower, WInKQCL, etc) as well as computerized labs instruments are deployed with proper and right sized validation documents at LP1. Once systems and Instruments are deployed, this role will evolve into monitoring, execution, and maintenance of the Laboratory IT Systems and Instruments, with an emphasis on continuous improvement, especially with regards to data integrity. This role will harness a deep understanding of CSV and Data Integrity principles ensuring compliance with regulatory requirements, consistent application, and sustainability for local and global Technology at Lilly systems, and labs instruments used at the LP1 site. This role will collaborate with the local and global Computer System Quality Assurance team and Technology at Lilly organization to enable standard methodologies, processes, and governance to consider new points to strengthen the Technology at Lilly CSV and Data Integrity position and align with corporate objectives and initiatives.

How You’ll Succeed

• Leads and/or supports the laboratory with the validation of laboratory equipment and software systems including computerized analytical instrument qualification (IQ/OQ/PQ) and computerized system validation across GAMP 5 software categories.
• Supports the establishment and maintenance of the validated state of software-based computerized systems and lab instruments in use in the lab, including ownership of periodic review cycles to confirm ongoing compliance and fitness for intended use.
• Partner multi-functionally with site DI SMEs to ensure a common, systematic approach to meeting existing and new DI/CSV expectations. This includes, but is not limited to, audit trail management, workstation security, and connecting stand-alone equipment.
• Supports site deployment and upgrade of laboratory IT systems such as MODA, Empower, NuGenesis, and LabVantage with any CSV needs
• Partners and establishes relationships with Global Quality Laboratory Network, Global and Site IT team members, Computer System Quality Assurance (CSQA), site Quality Assurance, and external vendor/supplier organizations.
• Provides oversight and supports continuous improvement of systems/instruments as they relate to the labs
• Applies knowledge of quality principles, cGMP, and laboratory systems towards the development and execution of local procedures, training courses, and practices
• Manages and supports both internal or external audit and inspection activities for the laboratory.
• Performs change control, investigations, root cause analysis, and activity planning
• Performs System Administration for E3B system
• Coordinate the technical evaluation with site Tech@Lilly subject matter experts (SMEs) of new and existing systems from a Data Integrity and CSV perspective for both labs systems and computerized labs instruments.
• Provide CSV consulting and assist with articulation of CSV needs to the CSV third party service provider(s).
• Lead and participate in DI/CSV related deviations and CAPAs in the scope of LP1 labs area.
• Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only.
• Leads team of contract resources in the management and support of labs instruments

Your Basic Qualifications

• Bachelor of Science degree in IT, Engineering, Computer Science, or related field
• 5+ years of relevant work experience in CSV capacity working in a regulated industry (i.e., GMP) and solid understanding of quality processes in IT that applies to manufacturing.
• 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.

What You Should Bring

• Strong Data Integrity (DI) knowledge with demonstrated background of having implemented solutions to enhance data integrity in both computerized systems and instruments.
• Proficiency with CSV and ability to right-size validation based upon risk.
• Solid knowledge of Computer System Validation process and Data Integrity.
• Good communication and interpersonal skills to build relationships with collaborators and articulate complex technical concepts.
• Strong analytical and problem-solving skills to identify and resolve technical issues related to Labs systems, configurations, or integrations. Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related).
• Ability to effectively prioritize and raise issues.
• Adaptability and flexibility to work in a fast-paced environment and manage multiple tasks simultaneously.
• Solid knowledge of Computer System Validation, GAMP, and GMP.
• Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving techniques.
• Effectively prioritize and raise issues
• Demonstrated learning agility and curiosity
• Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions
• Understanding of cybersecurity concepts and standard methodologies related to IT technologies.
• Build solutions using an agile framework for the entire solution lifecycle including designing, implementing, automating, modernizing, maintaining, and optimizing solutions.
• Experience with technical mentoring and developing technical team members.
• Exposure to international operations, diverse teams, global IT projects, or working in a global organization.
• Experience deploying new system implementations
• Experience in standing up greenfield facilities

Other Information

• Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.

Position will be based out of the Lebanon, IN site with ability to travel to other US and global Lilly sites as required.