Lilly Associate Director, Parenteral Engineering in Concord, North Carolina
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 35,000 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 Associate Director of Parenteral Engineering is responsible for the staffing, training, and leadership of the robotics, logistics and systems administrator engineering group (both process and automation) supporting asset delivery, process development, commissioning, qualification, validation, and startup of the Parenteral area as well as other engineering automation systems. After startup, the Associate Director of Parenteral Engineering will be responsible for supporting the day-to-day engineering activities as well as planning for the 3 - 6-month horizon. The Associate Director of Parenteral Engineering is expected to lead by example and provide coaching to others in the areas of safety, quality, engineering, and continuous improvement.
KEY OBJECTIVES / DELIVERABLES:
Support Site Leadership to build a diverse and capable site organization based in engineering first principles.
Deliver the parenteral 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.
Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
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).
This role has direct interaction with Regulatory Agencies during site inspections.
Understand and influence the manufacturing control strategy for their area.
Represent their staff on the Plant Flow Team.
The Associate Director is responsible for a professional staff of approximately 10 individuals supporting both process engineering and automation.
REQUIREMENTS (EDUCATION, EXPERIENCE, TRAINING):
Bachelor's degree in engineering
At least 7 years of automation and/or process engineering experience
PREFERRED ATRIBUTES BUT NOT REQUIRED:
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.
Ability to work 8-hour days – Monday through Friday
Ability to work overtime as required
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