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 Overview:
 

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing areas at Lilly’s new Lebanon, Indiana (LP2) site. The QA Operational Support position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, and start up to ensure regulatory approval of the facility. As the project progresses, this role will transition to site-based process team supporting one of the following manufacturing areas:

ATMP Gene Therapy Drug Substance ManufacturingATMP Gene Therapy Parenteral ManufacturingQC Laboratory  Packaging Warehouse LogisticsFacility, Utility and Maintenance

Responsibilities:

Knowledge of cGMP practices including good documentation practices, data integrity and regulatory complianceAct as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the designConsult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phaseActively participate in required design reviews and final design qualification activitiesProvide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality proceduresProvide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areasSupport the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staffFoster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work groupSupport the definition and execution of inspection readiness activities including support of site self-inspections in GQALead project initiatives needed in support of the project and Quality functionResolve or escalate any compliance issues to the project, site, and Quality ManagementProvides guidance for deviations, observation handling; change control proposals; document creation and revisions.

Basic Requirements:

Bachelor's degree in relevant field (preference for scientific or engineering field)3+ years working in the pharmaceutical manufacturing industry in Quality Assurance rolesPrevious experience with C&Q / Verification and Validation oversight including automation and computer systems validation

Additional Preferences:

Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturingASQ CertifiedComputer System Quality Assurance experiencePrevious facility or area start up experience Previous experience with gene therapy drug substance processes such as equipment prep, virus prep/banking, inoculation, purification, and/or drug product manufacturing processes such as formulation, filling/visual inspection, and packagingPrevious experience with lab equipment delivery and qualificationPrevious experience with management of utilities, facilities, maintenance, and warehouse logisticsPrevious experience with Manufacturing Execution Systems.Previous use of KNEAT – or other electronic validation softwareDemonstrated ability to communicate with and influence cross-functional teams including good oral and written communication skillsDemonstrated strong problem solving and decision making skillsPrevious technical writing experienceTechnical aptitude and ability to train and mentor others

Additional Information:

Ability to work 8-12 hour shifts onsiteDuring the project phase, this position will allow for a flexible working environment with the ability to periodically work remotely based on the scope and nature of the activities Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge 

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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