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Full-time

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Company: Eli Lilly and Company

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.

Organization 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 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 $3 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 MES System Integrator your main function is to Design, Develop, Deliver and Qualify the MES solution for the Facility You will also partner with the process automation and operations area and global Tech at Lilly teams to determine innovative ways to implement the MES recipes and implement and support global systems and components related to Manufacturing execution.

How You’ll Succeed:

  • Ensure site operational readiness from MES and Digital Execution Strategy
  • Dynamically adapt road map to site evolution/strategic directions, and new trends/issues.
  • Partner cross functionally locally and globally to establish and implement site IT roadmap
  • Establish a strong site culture based in Lilly values, expectations, and operational excellence standards.
  • Execute the MES strategy for Lebanon.
  • Proactively influence the business towards replication & standardization to drive value and implement the appropriate technical solutions.
  • Evaluate and translate functional requirements into 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
  • Accurately translate business processes into technical terms and vice versa
  • Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the quality control laboratory, 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
  • Partners and builds relationships with Global MES Groups, Global and Site team members
  • Acts as Tech@Lilly key contact SME for MES IT systems
  • 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 of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
  • At least 5 year of relevant work experience in MES and DCS integration
  • Professional experience working in a GXP, regulated environment.

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.

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.

#WeAreLilly

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