MES Systems Engineer

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Position Description:

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 individuals 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!

What You’ll Be Doing:

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

As an MES System Engineer 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 Tech at Lilly teams to determine innovative ways to implement and support MES recipes, systems, and components related to manufacturing execution and excellence.

How You’ll Succeed:

· 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 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.

What You Should Bring:

· 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

· Effectively prioritize and escalate issues

· Demonstrated learning agility and curiosity

· Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions

Basic Qualifications:

· Bachelor Degree in one of following disciplines - Science degree in IT, Chemistry, Pharmacy, Science or Engineering.

· At least 5 year of relevant work experience in MES and DCS integration

· Experience working in a GXP regulated environment.

Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to

F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

· Previous Agile experience.

Other Information:

· Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.

· Position will be based out of the Lebanon, IN site with ability to travel to other US and global Lilly sites as required.