Engineer - MES - Lebanon LP1

Lilly • Lebanon, IN

2d • Onsite

About The Position

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!

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

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

Requirements

• Must have Strong Analytical and Problem-solving skills.
• Must have Excellent communication skills.
• 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
• 3+ year of relevant work experience in MES (Syncade or Pharmasuite) and DCS integration
• Professional 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.

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 at 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, 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
• 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