Lab IT Systems Lead — Validation & Data Integrity

Eli Lilly and Company•Lebanon, IN

4d•$64,500 - $151,800•Onsite

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. 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 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

Requirements

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 agility and curiosity
Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions
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.

Nice To Haves

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

Responsibilities

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 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