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.

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

$63,750 - $145,200

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 38,000 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 individuals who are determined to make life better for people around the world.

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 Tech at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Tech at Lilly MQ strives to enable the making of medicine “with safety first and quality always”.

As Laboratory System Integrator your main function is to partner with the quality control functional area and global Tech at Lilly teams to implement and support digital laboratory solutions to support the organizational objectives of the Lebanon API Manufacturing site.  Responsibilities will involve interacting with global Tech at Lilly and local site support functions to configure systems and assist with installing and qualifying laboratory IT systems such as LIMS/LES (LabVantage, MODA), ELN (NuGenesis), and other lab systems (Empower, WinKQCL). The role will evolve into monitoring, execution, maintenance, and continuous improvement of the Laboratory IT Systems for the QC lab with an emphasis on continuous improvement, especially with regard to data integrity.  This role will serve as a representative for laboratory IT systems and will be responsible for mentoring and educating peers on the use of lab systems, supporting audits, and oversight for management reviews, laboratory metrics, laboratory equipment, and laboratory documentation.

How You’ll Succeed:

Expand the laboratory systems stack knowledge and understand local laboratory procedures.Support and configure laboratory equipment inside LIMS/LES (LabVantage, MODA), ELN (NuGenesis), and other lab systems (Empower, WinKQCL)to ensure correct execution of laboratory testingAssists site deployment and upgrade of QC laboratory IT systems such as MODA, Empower, NuGenesis, and LabVantageAccurately translate business processes into technical terms and vice versaBuild and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the quality control laboratory, and ensure that solution requirements complyDeliver and support laboratory systems stack to start up new quality control lab operations inside the Lebanon API Manufacturing siteWork with global system teams to ensure operational readiness of laboratory systems to support the operational objectives of the LP1 facility (i.e. validation plans, standard operating procedures, training, etc.)Produce and maintain project and validation documentationEnsure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirementEnsure the incident, problem, configuration, and change/release management are all accomplished in alignment with and understanding of business needsPartners and builds relationships with Global Quality Laboratory Network, Global and Site team membersActs as Tech@Lilly key contact SME for QC laboratory IT systemsDevelops training materialsMust have Strong Analytical and Problem-solving skills.Must have Excellent communication skills.

What You Should Bring:

Deep knowledge and experience with Laboratory Systems in a GMP Environment (Lab Vantage, MODA, Empower, NuGenesis)Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.Solid knowledge of Computer System Validation processDemonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving skillsEffectively prioritize and escalate issuesDemonstrated learning agility and curiosityDemonstrated ability to understand quality control business processes and convert into IT requirements/solutions

Basic Qualifications:

Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field1+ years of relevant work experience in information technology, engineering, computer system validation, quality control support or related areasProfessional experience working in a GXP, regulated environment.

Additional Preferences:

Previous Agile experience.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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