Sr. Manager - Engineering

Eli Lilly Eli Lilly · Pharma · Concord, NC

Senior Manager of Engineering responsible for supporting asset delivery, process development, commissioning, qualification, validation, and startup of the Parenteral/DAP area and other engineering systems. The role involves leading a team of 5-10 individuals and ensuring business plan goals related to safety, quality, and efficiency are met. Requires a Bachelor's degree in Engineering, at least 5 years of engineering experience, and pharmaceutical experience. Experience with regulatory agencies (FDA, EMEA), automated equipment, combination products, and facility startups is preferred.

What you'd actually do

  1. Build a diverse and capable engineering organization based in engineering first principles.
  2. Deliver the parenteral/DAP scope and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation.
  3. Provide leadership and develop objectives to deliver Business Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency.
  4. Participate in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), and Failure Modes Effect Analysis (FMEA).
  5. Represent their staff on the Process Team.

Skills

Required

  • Bachelor's degree in Engineering
  • 5 years of engineering experience
  • Pharmaceutical Experience

Nice to have

  • management or leadership experience
  • leading or working effectively with a cross functional group
  • highly automated equipment
  • combination products
  • device assembly
  • pharmaceutical packaging
  • drug product formulation and filling in aseptic environment
  • facility or area start up experience
  • equipment qualification
  • process validation experience
  • Manufacturing Execution Systems
  • electronic batch release
  • deviation and change management systems including Trackwise

What the JD emphasized

  • Pharmaceutical Experience
  • FDA
  • EMEA