Engineer - Mes - Lebanon Lp1

Eli Lilly Eli Lilly · Pharma · Lebanon, IN

This role is for an Engineer focused on Manufacturing Execution Systems (MES) in a pharmaceutical manufacturing setting. The primary responsibility is to design, develop, deliver, and qualify the MES solution for a new drug substance manufacturing site. The role involves partnering with automation and operations teams, ensuring operational readiness, adapting project roadmaps, and maintaining system validation. A key requirement is the ability to incorporate AI tools into daily workflows to improve MES recipes and activities, alongside a strong understanding of GMP and regulatory requirements.

What you'd actually do

  1. Ensure site operational readiness from MES and Digital Execution Strategy
  2. Execute the MES design, implementation, and support strategy for Lebanon API.
  3. Develops \ assists in the creation and maintenance of the MES interfaces with other Lilly systems
  4. Coordinate with the business in gathering and understanding their requirements and translate them into an appropriate solution within the MES system
  5. Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement

Skills

Required

  • 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.

Nice to have

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

What the JD emphasized

  • Must have demonstrated the ability to incorporate AI tools into daily workflow to accelerate development and continuous improvement of MES recipes and related activities
  • Understanding of regulatory requirements in GMP (Good Manufacturing Practice), such as FDA regulations for pharmaceutical manufacturing.
  • Solid knowledge of Computer System Validation process
  • Professional experience working in a GXP, regulated environment.