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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.

POSITION DESCRIPTION:

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.

Other Information:

Ability to work 8-hour days – Monday through Friday

Ability to work overtime as required

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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).

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