Engineer - Quality - FUME

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associates to support our growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Engineer - Quality - FUME provides oversight, guidance and support in the area of Facilities, Utilities, Maintenance, and Equipment (FUME). This position is essential for maintaining GMP compliance and ensuring inspection readiness.

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; accountable for supporting all Health, Safety, and Environmental Corporate and Site Goals.
• Leads, mentors, and coaches operations and support personnel on FUME quality matters.
• Acts as a QA SME, working with Global Facilities Delivery, Lilly project staff, Global Computer Systems QA, and selected service provider firms to complete the detailed design of the assigned areas employing QbD and Quality Risk Management (QRM) principles and ensuring the integration of Lilly Global Quality System requirements into the design and delivery of facilities, assets, and systems.
• Provides technical and quality review and approval of facility, utility, and equipment system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
• Provides quality oversight for the verification and qualification of facility, utility, and equipment systems including review of test cases, test execution, test summaries, and discrepancy resolution.
• Provides QA oversight of maintenance activities including initial calibrations and maintenance plan development.
• Provides mentorship and QA oversight for change management, QRM, process validation and equipment validation efforts.
• Works with the site quality to support the development of the vision and strategy for the overall site quality operation with focus on the FUME areas.
• Supports the site organization in building technical capability, for a diverse cross‑functional staff in Quality, project teams, and area process teams, including mentoring of new Quality and other project staff.
• Fosters a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Leads project initiatives needed in support of site continuous improvement, site expansion, and the Quality function.
• Resolves or escalates any compliance issues to the project lead, site leadership, and Quality Management.
• Support the QA Compliance team and site in the execution of the site readiness plan with focus on supporting start‑up and ongoing quality oversight of site FUME systems including working as part of the site Utilities Process Team and Business Quality Assurance for local computer systems.

• Bachelor's degree in a science, engineering, or pharmaceutical‑related field of study or equivalent experience.
• Minimum 3‑5 years in the pharmaceutical industry with specific Quality FUME experience.
• On‑site presence required.

• Demonstra…