Engineering Systems Lead

2 weeks ago

Durham, United States Eli Lilly Full time

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.

Lilly unites caring with discovery to create medicines that make life better for people around the world.  Lilly is a fortune 500 company that has been in operation for over 140 years.  We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina.  This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up.

The Engineering Systems Lead is responsible for the staffing, training, and leadership of the CQV contractors.  The Engineering Systems Lead is also responsible for supporting asset delivery, process development, commissioning, qualification, validation/verification and startup of the organization and site.  After startup, the Engineering Systems Lead will be responsible for supporting the day-to-day engineering organizational activities, being the site SME of engineering systems/programs and helping to train, onboard, develop and guide the organization’s engineers and technicians.

Key Objectives/Deliverables:

  • Technical Lead for CQV, Verification and Training Programs
    • Support capital project delivery by onboarding and managing CQV resources
    • Verification Strategy SME
    • Kneat Power User
    • Training lead for special OJT skills such as temperature mapping and defect analysis in visual inspection
    • Global Parenteral Network training lead
  • Establish RTP Engineering Strategies and Alignment to Standards
    • Manage vendor responsible for engineering drawings
    • Manage the RTP instance of the GECMS
    • 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).
    • Manage mapping RTP practices and procedures to engineering standards
    • Ensure Alignment to Tech Center resources
    • Manage and establish the asset qualification monitoring program at the RTP site, train users of the program and serve as the site SME
    • Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
  • Enable the Success of RTP Team Lilly
    • Develop an engineering onboarding program
    • Site MSOE lead
    • Any other responsibilities to support the success of the RTP organization

Minimum Requirements:

  • At least 7 years of engineering/CQV experience

Additional Preferences:

  • Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
  • 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 experience with Manufacturing Execution Systems and electronic batch release.
  • Previous management or leadership experience including leading or working effectively with a cross functional group
  • Excellent interpersonal, written, and oral communication skills
  • Ability to work using own initiative
  • Strong technical aptitude and ability to train and mentor others
  • Ability to balance a number of priorities and tasks simultaneously
  • Previous experience with deviation and change management systems including Trackwise.

Education Requirements:

  • Bachelor's degree in engineering

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 ( Lilly_Recruiting_Compliance@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.

#WeAreLilly

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