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 is completing the build out of a new state of the art Parenteral manufacturing, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.
The Operations Associate (OA) will report to an Associate Director of Device Assembly Operations. The OA will be responsible for providing leadership within the area's process team, managing projects and process improvements, acting, as a liaison between operations and multiple functional groups to support event management, change controls, etc. The OA will also assist the operations team in the day to day management of the production floor and lead investigations and drive implementation of actions associated with deviations.
Key Objectives/Deliverables:
- Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Device Assembly areas.
- Monitor and build a strong safety culture
- Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.
- Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
- Understand and influence the manufacturing control strategy for their area.
- Trained as a Lead Investigator
- Development and monitoring of metrics for the area
- Aid in issue resolution, batch/product approvals, and production schedule execution.
- Lead specific activities of the process team.
- Potential back-up of Associate Director/Manager
- Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals
Minimum Requirements:
- Bachelors degree (or equivalent work experience in cGMP production)
- Experience: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals
Additional Preferences:
- Technical or Science degree preferred
- Previous leadership/supervisory experience helpful
- Career interests in Operations Leadership
- Device Assembly or Packaging experience
- Ability to travel up to 10%
- Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
- Excellent interpersonal, written and oral communication skills
Other Information:
- The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.
- Must be flexible to attend meetings or support off-shifts (operations is 24/7)
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$64,500 - $140,800
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.