Quality Assurance – 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 35,000 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 people who are determined to make life better for people around the world.

Organization Overview:

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.

Eli Lilly and Company is breaking ground on a new facility in Lebanon, Indiana with the mission to manufacture Active Pharmaceutical Ingredients (APIs). This site (LP1) will provide manufacturing capabilities for traditional small molecules, synthetic peptides, and new modalities as well as the utilities, warehousing and laboratories needed to support these operations. A Quality Assurance – Engineer is responsible for quality and compliance oversight of the C&Q (verification) efforts for one or more of LP1’s manufacturing capabilities (nodes). Responsibilities include but are not limited to review and approval of asset delivery documents (URS, DR/DQ, test plans, etc.), issue/discrepancy resolution, audit of Good Engineering Practice, and preparation of quality system documents (SOP, strategies, etc.). This role will ensure consistent application of Lilly’s Quality Management System across the LP1 Site by partnering with other node QA – Engineers and project QA Leadership. As the project progresses, this role will transition to the site-based QA organization.

Responsibilities:

The Quality Assurance – Engineer, will provide commission and qualification (Asset Delivery) quality assurance oversight during the design and start-up phases of one or more of manufacturing or support capabilities at Lilly's Lebanon, Indiana API manufacturing site (LP1).

• Ensure consistent integration and application of Lilly’s Global Quality System requirements into the design, verification, and start-up activities within assigned node(s) of LP1 (Small molecule, Peptide, Lab, Warehouse, Utilities, etc.)
• Provide QA review and approval of project Asset Delivery documents ensuring compliance with Lilly Global Quality Standards as well as project and/or local quality procedures.
• Partner with project and site Quality leadership to advance the vision and strategy for the overall site quality function (focus on the FUME topics).
• Lead project initiatives needed to support assigned node(s) of the LP1 project and/or site Quality function.
• Resolve or escalate any quality or compliance issues to project and/or site Quality leadership.
• Audit project and/or site operation against applicable Corporate Engineering, Global Quality or Site standards and procedures.
• Ensure data integrity principles are integrated into design and verification efforts.

Basic Requirements:

• Bachelor's degree in engineering preferred; Science-related field will be considered.
• Minimum 2 years of experience within pharmaceutical manufacturing in QA role.
• Minimum 1 year of experience with equipment Commission and Qualification.

Additional Skills/Preferences:

• Experience with facilities, utilities, and equipment systems qualification including regulations governing them.
• Demonstrated knowledge and application ISPE C&Q and ASTM E2500 principles.
• Previous API facility or unit operations experience. (batch and continuous reactors, filtration, chromatography, centrifuge, dryer, utilities, air handlers, cleanrooms)
• Demonstrated strong oral and written communication.
• Demonstrated strong interpersonal interaction skills and ability to influence cross-functional organizations.
• Demonstrated strong problem-solving and decision-making skills.
• Quality certification - American Society for Quality (ASQ) – preferable

Additional Information:

• Ability to work 8-hour days – Monday through Friday
• Ability to work off hours as required.
• During 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 is located LTC (Indianapolis) until Lebanon site is available. Travel may be required (10-25%).

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.

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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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