Lab IT Systems Lead — Validation & Data Integrity

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.

Position Brand 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 utilize 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 best practices, 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 cross-functionally with site DI SMEsto 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

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 demonstrated ability to right-size validation based upon risk.
• Solid knowledge of Computer System Validation process and Data Integrity.
• Excellent communication and interpersonal skills to build relationships with stakeholders 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 escalate 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 escalate issues
• Demonstrated learning agilityand curiosity

• Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions

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 strong 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.

Additional Preferences:

• Understanding of cybersecurity concepts and best practices 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.
• Previous Agile experience.
• 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.

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), enAble (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

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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