MES Systems Engineer
Eli Lilly and Company
Summary
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.
Job description
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 - ideally in the following disciplines - Science degree, 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
Additional Preferences
- Previous Agile experience
Requirements
- Bachelor Degree in Science, IT, Chemistry, Pharmacy, Science or Engineering
- At least 5 years of relevant work experience in MES and DCS integration
- Experience working in a GXP regulated environment
- Deep knowledge and experience with Manufacturing Execution Systems
- Understanding of GMP regulatory requirements such as FDA regulations for pharmaceutical manufacturing
- Solid knowledge of Computer System Validation process
- Strong analytical and problem-solving skills
- Excellent communication skills
- Must be authorized to work in the United States on a full-time basis
- No visa sponsorship provided
Benefits
- 401(k) Matching
- Pension
- Vacation Benefits
- Medical, Dental & Vision
- Prescription Drug Benefits
- Flexible Spending Accounts
- Life Insurance
- Death Benefits
- Employee Assistance Program
- Fitness Benefits
- Employee Clubs & Activities
- Company Bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.