Senior / Principal Process Engineer - APIEM

Position Overview

• Location Type: Onsite (CM manufacturing site in France)
• Job Type: Full time
• Salary: Not Specified

This position reports to the Director - Engineering API EM and provides technical leadership and expertise to contract manufacturer (CM) personnel. The role focuses on the reliable supply and commercialization of medicines with a strong emphasis on safety and quality. The Senior / Principal Process Engineer - APIEM will be a key member of the joint process team (JPT), contributing to validation and commercial supply efforts.

Responsibilities

• Provide on-site technical presence at the CM to supplement existing API EM Internal Process Teams.
• Oversee and support the CM to ensure right-first-time and on-time manufacturing execution, including:
  • PV-readiness, MBR walkdowns, campaign readiness.
  • Daily production areas walkthroughs.
  • Support major investigations and troubleshooting.
• Develop and sustain process knowledge to ensure the execution of appropriate product, process, and operational control strategies at the CM.
• Direct and indirect interaction with CM personnel to ensure reliable supply through the CM's execution of the operational control strategy.
• Conduct FUME assessments to understand risks to the operational control strategy.
• Participate with internal or CM resources in equipment specification, procurement, and IQ/OQ/PQ.
• Participate with internal and CM resources to assess HSE and PSM elements of the CM impacting Lilly products.
• Engage with internal and external resources in developing capabilities with new or evolving technologies impacting portfolio assets.
• Adhere to Lilly Red Book expectations when interacting with the CM.

Key Objectives/Deliverables

• Coach and Mentor Process Team Members:
  • Provide insight and feedback to Lilly / CM Joint Process Team (JPT) members based on experience with unit operation control.
  • Support and peer review root cause analysis for FUME and operational incidents.
  • Peer review documentation of learning points, technical studies, and incident investigations.
• Develop and Sustain Process Knowledge:
  • Identify process knowledge gaps impacting equipment and process capability.
  • Develop or support the capture of key process knowledge (e.g., material and energy balances, kinetics, chemistry, process modeling, equipment design basis).
  • Enable the development and maintenance of process knowledge infrastructure (e.g., models, report history, lab models, literature).
  • Utilize optimization resources and tools for process analysis and improvement studies.
  • Review and track key process engineering metrics.
• Provide Process & Equipment Support:
  • Identify systemic issues affecting production and reliable supply from the CM.
  • Lead or participate in root cause analysis and countermeasure development/implementation for major safety, quality, or throughput incidents.
  • Perform reviews of incident documentation for technical accuracy.
  • Review and approve documentation and engineering decisions.
  • Conduct practice vs. procedure walk-throughs at CM sites.
  • Perform periodic housekeeping / fit & finish walk-throughs with area management.
• Process Optimization & Continuous Improvement:
  • Support development and technical analysis for ongoing continuous improvement activities.
  • Review and identify cost reduction opportunities.

Company Information

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 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 people who are determined to make life better for people around the world.