Sr. Manager - Engineering

Eli Lilly and CompanyConcord, NC
Onsite

About The Position

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, with 39,000 employees worldwide. Our mission is to discover and bring life-changing medicines to those who need them, improve disease understanding and management, and contribute to communities through philanthropy and volunteerism. We prioritize people and strive for excellence. The Senior Manager of Engineering is responsible for supporting asset delivery, process development, commissioning, qualification, validation, and startup of the Parenteral/DAP area as well as other engineering systems. This role involves supporting day-to-day engineering activities and planning for the 1-3 month horizon.

Requirements

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

Nice To Haves

  • Previous management or leadership experience including leading or working effectively with a cross functional group
  • Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
  • Previous experience with highly automated equipment.
  • Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment.
  • Previous facility or area start up experience.
  • Previous equipment qualification and process validation experience.
  • Previous experience with Manufacturing Execution Systems and electronic batch release.
  • Previous experience with deviation and change management systems including Trackwise.

Responsibilities

  • Build a diverse and capable engineering organization based in engineering first principles.
  • Deliver the parenteral/DAP scope and supporting systems through user requirements, design, build, commissioning, qualification, validation, and subsequent operation.
  • Provide leadership and develop objectives to deliver Business Plan Goals as it relates to safety, quality, and equipment/process effectiveness and efficiency.
  • 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).
  • Understand and influence the manufacturing control strategy for their area.
  • Represent their staff on the Process Team.
  • Responsible for a professional staff of approximately 5-10 individuals supporting process engineering and/or automation.

Benefits

  • eligibility to participate in a company-sponsored 401(k)
  • pension
  • vacation benefits
  • eligibility for 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)
  • company bonus (depending, in part, on company and individual performance)
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