Engineer - MES

Eli Lilly and Company • Lebanon, IN

1d • Onsite

About The Position

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, with 38,000 employees globally. Lilly is experiencing significant growth, investing over $13 Billion to establish a new state-of-the-art manufacturing site for Drug Substance in Lebanon, Indiana. This brand-new facility will feature the latest technology for API Manufacturing and Technology, utilizing advanced, highly integrated, and automated manufacturing systems with a focus on environmental impact minimization. This role offers a unique opportunity to contribute to building and operating this new site. You will be part of Tech@Lilly MQ (Manufacturing and Quality), an organization dedicated to driving manufacturing operational excellence and productivity through technology, ensuring medicine is made "with safety first and quality always". As an Engineer - MES, your primary function will be to Design, Develop, Deliver, and Qualify the Manufacturing Execution System (MES) solution for the facility. You will also collaborate with process automation, Process Operations Teams, and Global Tech@Lilly teams to innovate and support MES recipes, systems, and components crucial for manufacturing execution and excellence.

Requirements

• 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 workflow to accelerate development and continuous improvement of MES recipes and related activities
• Effectively prioritize and escalate issues
• Demonstrated learning agility and curiosity
• Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions
• Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field
• At least 3 year of relevant work experience in MES and DCS integration
• Professional experience working in a GXP, regulated environment
• Strong Analytical and Problem-solving skills
• Excellent communication skills
• Qualified applicants must be authorized to work in the United States on a full-time basis

Nice To Haves

• Preference for Emerson DeltaV MES (Syncade) Experience
• Previous Agile experience

Responsibilities

• 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@Lilly key contact SME for MES IT systems and be prepared to participate in and support site audits
• Develops training materials

Benefits

• Company bonus (depending, in part, on company and individual performance)
• Company-sponsored 401(k)
• Pension
• Vacation benefits
• Medical benefits
• Dental benefits
• Vision benefits
• Prescription drug benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance
• Death benefits
• Certain time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees