Manufacturing Operations Engineer - Advanced Therapies

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 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.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in 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, 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 start up the facility for both clinical and commercial supply. 

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up.

The Operations Associate (OA) for the Lilly Advanced Therapies Manufacturing Facility, LP-2, Lebanon, Indiana, will be a leadership development role, responsible for successful delivery of production areas and gene therapy facility startup. These responsibilities include process design, planning, and seamless start-up of GMP production.

In this role, you will be required to build deep operating expertise in their area of responsibility (including in-depth knowledge of the site operating systems and processes), have a strong working knowledge of the laboratory and manufacturing equipment set, control systems, and consistently demonstrate strong data-driven decision-making and problem-solving capabilities. They may also work to ensure that the processing suites are in-control, compliant, and maintained in a validated state through continual monitoring. The OA may play a role in implementing new technologies and operational process improvements in the GMP manufacturing environment.

• Assisting the Process Team Leaders with leading the Process Teams, specifically focusing on safety, quality, and manufacturing performance using appropriate performance metrics and targets.
•  Ensure cGMP readiness of manufacturing areas for start-up and process qualification activities.  Participate in and support training and engineering runs.
• Responsible for supporting validation activities and ensuring GMP production areas are within compliance.
• Support and maintain a safety-first culture emphasizing individual accountability, safe systems of work, and management commitment.
• When required (and per delegation procedure), in the absence of the Associate Director-Manufacturing provide continuity to the Process Team activities and operational aspects of the process; escalate issues to the Senior Director of Manufacturing Operations as needed.
• Lead or participate in continuous improvement projects through capacity optimization and cost reduction programs.
• Support the development and drive the Operational Excellence Roadmap for LP2 Flow Team.
• Lead Manufacturing Projects with the support of cross-functional stakeholders.
• Support authoring and revision of standard operating procedures and batch records as required.  Review technical reports.  Conduct deviation investigations and write process deviation reports.
• Document and appropriately communicate all aspects of work and learnings
• Provide training and mentorship for new personnel

• Bachelor’s degree in engineering or related technical field
• 3+ years of Engineering or Technical Services Experience

• Demonstrated operational capability with high productivity
• Proven track record of curiosity with learning agility
• Demonstrated excellent problem-solving skills
• Self-starter with high initiative and data-driven approach to problem-solving
• Demonstrated ability to participate in and facilitate technical decision-making
• Demonstrated strong interpersonal skills with demonstrated adaptability and flexibility to working in different environments, teams etc.
• Demonstrated strong verbal and written communication skills
• Strong interest in leadership including cross-functional operations leadership
• Strong verbal and written communication skills
• Strong technical writing skills with attention to detail.
• Excellent problem-solving skills.
• An understanding of key technical services deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification.
• An understanding of normal process variability (expected) and special cause variability.

• Normal workday: 8 hour days – Monday through Friday
• Must be flexible to attend meetings or support off-shifts as necessary
• Some OUS and US travel may be required (<10%)

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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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.

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