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 and Role Overview:

Lilly is entering an exciting and outstanding period of growth. The Manufacturing and Quality (MQ) Tech at Lilly organization is engaged in an exciting phase of transformation as we drive our Digital Plant vision across Lilly manufacturing at the same time supporting unprecedented growth in Lilly’s manufacturing operation across the world.

This position develops, deploys, and supports laboratory and/or manufacturing systems to meet business and regulatory needs. This position requires business area knowledge and computer expertise to provide in-depth support for new and existing laboratory and/or manufacturing applications, systems, and computerized equipment. This position will be responsible for the maintenance, updates and troubleshooting of Lab Systems (ie LIMS, Nugenesis, SoftMax Pro, LabVantage) related items. Additionally, this position will assist with site projects such as system updates and/or enhancements. This individual will solve computerized system issues, analyze information, implement new systems, and maintain and enhance existing solutions in accordance with corporate standards and guidelines. This role will collaborate with global IDS teams to meet goals for both current and anticipated future needs for new and existing technologies, practices and initiatives.

Responsibilities:

Create, modify, and enhance applications and systems to satisfy business information demands. Facilitate changes by delivering feedback from customers to application teams and communicate any changes applied ensuring operational procedures stay current and relevant.Assure adherence of applicable regulatory (i.e. cGXP, CFR, etc.) practices during execution of all work activities. Participate in audits, inspections, and associated readiness activities.Support and participate in LIMS related projects for upgrades and enhancements including change control impact assessments.Be responsible for and participate in the installation, configuration, and validation of LIMS applications. Develop and implement project plans, ensuring timely and quality delivery of solutions. Manage system customizations, scripts, and user interface enhancements.Proven ability to translate and lead complex lab/scientific requirements into LIMS capabilities.Design and implement integrations between LIMS, SAP and third-party systems (ie Empower, etc), including instruments and databases.Responsible for daily support of end users, and provide end user trainingPerform the pre-validation assessment of all computerized laboratory and/or manufacturing systems, ensuring that all validation requirements have been met prior to system testing.Enable data-driven decision making in pharmaceutical Quality Control and Manufacturing by developing and deploying interactive, easy-to-use dashboards and reports that support self-service analytics, ensure secure and compliant access to critical data, and provide real-time insights to enhance process efficiency, product quality, and regulatory compliance.Identify, recommend, and implement automated solutions to address QC laboratory or manufacturing operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. Train and assist business users in proper use of applications and computerized systems.Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with the customers and other members of the IDS organization. Inspire and recognize teamwork.Serve as a liaison between local and corporate systems groups, cross-functional or cross-site teams, as requested, interfacing with system owners, IDS, QC, QA, Manufacturing, AEG, vendors, and other relevant functional areas. Build enterprise and cross-site connections to ensure integration and results.Develop and implement a change management strategy in partnership with cross-functional initiative teams.Identify, analyze, prepare risk mitigation tactics, and manage anticipated resistance.Consult and coach project teams and support communication and training efforts.Integrate change management activities into project plans.Define and measure success metrics and monitor change progress.Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk, and follow quality management practices. Support and abide by applicable Lilly policies as indicated in the Lilly Red Book and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.

What You Should Bring:

Experience and knowledge of change management principles, methodologies, and tools.Exceptional communication skills – both written and verbal.Experience with large-scale organizational change efforts.Extensive experience leading change, communication and training efforts for multiple global, complex technology implementations.Ensure that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies).Provide IDS technical and/or validation direction related to computer system Change Management initiatives, as well as the selection, implementation, and upgrade of computerized systems.  Support validation processes, including IQ/OQ/PQ documentation and audits.Desire to establish and maintain relationships with all levels across the company and external partners.Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.Experience in health care, pharma, manufacturing or life sciences is a plus.Flexible and adaptable; able to work in ambiguous situations.

Basic Requirements:

Bachelor’s degree in engineering, Computer Science, Information Technology, or a related technical field.5+ years IT or equivalent relevant experience, with a basic understanding of databases (Oracle, SQL, etc.) and operating systems (Windows, etc.).2+ years in a regulated environment Pharmaceuticals or Life Sciences industry, maintaiing excellent working knowledge of pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications.

Additional Skills/Preferences:

MS/MBA desirable.Ability to work on multiple concurrent project initiatives.Experience with managing external (vendor, consultant) business partners.Effective problem-solving and analytical skills to resolve operational problems.Excellent written and verbal communication skills with the ability to develop and present both business and technical presentations.Ability to build relationships across dimensions of difference, ask questions and invite others to contribute.Demonstrated business acumen.Speak up with ideas, concerns and to ensure safety of others.Demonstrated learning agility, and ability to think creatively, try new insights and apply learnings.Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.Strong collaboration with colleagues at all levels.Demonstrated success in influencing without authority.Strong customer service and teamwork oriented.Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.Highly flexible, adapting to changes in priorities, requirements and processes is required.Solid understanding in the following systems is a plus: laboratory information management system (LIMS), LabVantage, NuGenesis, and additional laboratory standalone analytical application/computerized systems.Hands on professional experience in BI development using Power BI or Tableau.

Additional Information:

Travel: 0-10%May be required to be on call. 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.

This job specification is intended to provide a general description of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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

$70,500 - $198,000

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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