Sr. Principal Process Engineering Sme, Parenteral

Eli Lilly Eli Lilly · Pharma · Indianapolis, IN +4

This role is for a Senior Principal Process Engineering SME in Parenteral manufacturing at Eli Lilly. It involves providing global technical expertise in process engineering, aseptic processing, and parenteral technologies, including formulation, filling, freeze drying, and isolation systems. The role requires leadership in technical discipline, safety, compliance, consultation, knowledge sharing, capital project support, external manufacturing support, platform ownership, and innovation in manufacturing processes. A Bachelor's degree in engineering and over 10 years of cGMP manufacturing experience are required.

What you'd actually do

  1. Technical and Discipline leadership –Partners with other technical staff to direct discipline activities, oversight of the community, new technology development and technology assessments, creation and maintenance of Engineering Standards, Master specifications and Best Practices for the discipline, and coaching and mentorship of junior engineering staff.
  2. Safety and Compliance – Ensure personal and team compliance with all applicable regulatory and corporate policy requirements; ensure appropriate safety practices and procedures are in place and are followed to prevent injuries; ensures the ETC meets current Quality expectations and is a part of actively monitoring evolving Quality and other regulatory expectations related to engineering
  3. Consultation - Assists sites globally with technical evaluations, master planning, technology assessments, and specific problem resolution including troubleshooting and root cause analysis
  4. Knowledge sharing - Provides ongoing technical support to site engineering groups, domestic and global. Serves as a mentor to Lilly engineers with a focus on technical development and functional capability building. Interfaces with and develops site technical experts in Parenteral Engineering. Reviews and prepares protocols and technical reports.
  5. External Influence - Monitors and, when appropriate, influences change in external codes and standards on Lilly’s behalf. Ensures external learnings are effectively communicated within Lilly and works to ensure ongoing compliance with these learnings.

Skills

Required

  • Bachelors degree in engineering or related technical field
  • Minimum 10 plus years in cGMP manufacturing or manufacturing support experience with increasing technical responsibility
  • Extensive knowledge of parenteral processing equipment and operations including formulation, filling, freeze drying, and isolation equipment
  • Demonstrated ability to solve technical problems and implement projects
  • Deliverables include input and support of facility design, equipment layout, technical specifications, and equipment optimization, testing and qualification
  • Familiarity with technology advances in vial, cartridge, and syringe container closure systems
  • Strong interpersonal and communication skills

What the JD emphasized

  • cGMP manufacturing
  • parenteral processing equipment