Lilly Associate Director – DAP 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-Engineering - Device Assembly and Packaging is responsible for the staffing, training, and leadership of the engineering group (both process and automation) supporting asset delivery, process development, commissioning, qualification, validation and startup of the device assembly, and packaging lines. After startup, the engineering manager will be responsible for supporting the day-to-day engineering activities as well as planning for the 3 - 6-month horizon. The Associate Director 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 equipment, lines, 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.
Managers are responsible for a professional staff of approximately 20 individuals supporting both process engineering and automation.
REQUIREMENTS (EDUCATION, EXPERIENCE, TRAINING):
Bachelor's degree in engineering
At least 7 years process engineering and/or automation experience
PREFERED ATTRIBUTES, BUT NOT REQUIRED:
Previous management or leadership experience including leading or working effectively with a cross functional group
Excellent interpersonal, written, and oral communication skills
Strong technical aptitude and ability to train and mentor others
Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
Previous experience in engineering.
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 Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
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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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).