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, site 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 roadmap 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 MES 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, and other API Site technical team members.
• Acts as Tech at Lilly key contact SME for MES systems.
• Develops training materials.

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
• Must have Excellent communication skills
• 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 3 years 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 Lebanon, IN site with ability to travel to other US and global Lilly sites as required.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$63,750 – $145,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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