Sr. Manager - Engineering

LillyConcord, 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. 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. 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. The Senior Manager of Parenteral/DAP Engineering will be responsible for supporting the day-to-day engineering activities as well as 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

  • Support asset delivery, process development, commissioning, qualification, validation, and startup of the Parenteral/DAP area as well as other engineering systems.
  • Support the day-to-day engineering activities as well as planning for the 1-3 month horizon.
  • 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

  • Company bonus (depending, in part, on company and individual performance)
  • Company-sponsored 401(k)
  • Pension
  • Vacation benefits
  • Medical benefits
  • Dental benefits
  • 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)
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