Engineer - MES - Lebanon LP

Overview

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 38,000 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.

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $13 Billion to create a new state-of-the-art manufacturing site for Drug Substance, in Lebanon, Indiana. The brand-new facility will utilize a variety of Platforms and have the latest technology for API Manufacturing and Technology. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site.

The Lilly Lebanon API Manufacturing site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

You will be part of Technology at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Technology at Lilly MQ strives to enable the making of medicine “with safety first and quality always”.

As an Engineer - MES your main function will be to Design, Develop, Deliver, and Qualify the MES solution for the Facility. You will also partner with the process automation, Process Operations Teams, and Global Technology at Lilly teams to determine innovative ways to implement and support MES recipes, systems, and components related to manufacturing execution and excellence.

• Ensure site operational readiness from MES and Digital Execution Strategy
• Dynamically adapt project road map to site evolution/strategic directions, and new trends/issues.
• Partner cross functionally and build relationships with local and global teams to establish and implement the site IT roadmap
• Establish a strong site culture grounded in Lilly values, expectations, and operational excellence standards.
• Execute the MES design, implementation, and support strategy for Lebanon API.
• Proactively influence the business towards replication & standardization to drive value and implement the appropriate technical solutions.
• Ensure project and/or validation documentation is maintained during lifecycle & release management.
• Develops   assists in the creation and maintenance of the MES interfaces with other Lilly systems
• Coordinate with the business in gathering and understanding their requirements and translate them into an appropriate solution within the MES system
• Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the batch requirements, and ensure that solution requirements comply
• Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
• Ensure the incident, problem, configuration, and change/release management are all accomplished in alignment with and understanding of business needs
• Acts as the Tech at Lilly key contact SME for MES IT systems and be prepared to participate in and support site audits
• Develops training materials
• Must have Strong Analytical and Problem-solving skills.
• Must have Excellent communication skills.

• Deep knowledge and experience with Manufacturing Execution Systems
• Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.
• Solid knowledge of Computer System Validation process
• Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving skills
• Must have demonstrated the ability to incorporate AI tools into daily…