About the position
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 currently constructing an advanced manufacturing facility for production of API (Active Pharmaceutical Ingredient) molecules located in Lebanon, IN. This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Responsibilities
- Ensures that all team members are knowledgeable and compliant regarding safety procedures, policies, permits and practices.
- Initiates and leads accident, near miss reviews and incident notifications.
- Ensures proper housekeeping procedures are maintained.
- Responsible for compliance and meeting the quality standards as defined by cGMPs, the Global Quality Standards, local procedures.
- Development of the CEMS program at the site as needed, working closely with the HSE team.
- Management of the CEMS program and coordination with production, operations, maintenance, engineering, HSE, and vendors.
- Ownership of CEMS procedures, operations, compliance testing (quarterly and annual testing of systems, and deviation management).
- Development of CEMS maintenance and operations support, including for after hour and backup support.
- In collaboration with HSE, work with the Indiana Department of Environmental Management (IDEM) and the Environmental Protection Agency (EPA), as needed, to ensure compliance and address any regulatory concerns.
- Provide site subject matter expertise for CEMS and continuous improvement opportunities.
- Responsible for developing operations and maintenance personnel on the workings of CEMS across shifts up to 7 days a week, including flex time or overtime.
- Participate in any start-up activities, including commissioning and qualification, procedure writing, reviews, and training.
- Lead CEMS training to accomplish plant start-up and team goals.
- Flexibility to support other areas within the Maintenance, Engineering, and Facility teams.
Requirements
- Minimum of 5 years of experience in CEMS maintenance and management, in a manufacturing environment.
- Experience with CEMS requirements for VOC/TOC CEMS and Performance specifications 2 and 8.
- Familiar with certified gas audits (CGA) and Relative Accuracy Test Audit (RATA).
- Strong knowledge of standard operating procedures, in a cGMP environment and control systems.
- Familiarity with regulatory requirements for CEMS systems in pharmaceutical manufacturing facilities is preferred.
- Project management skills.
- Excellent problem-solving and troubleshooting skills.
- Strong leadership and communication skills.
- Proficiency in using CEMS diagnostic tools and software.
- Ability to learn, develop, and have a continuous improvement mindset.
- Understanding of applicable IDEM and EPA regulations.
Nice-to-haves
- BS/MS in engineering or 5 years of equivalent experience with CEMS.
- Experience with Building Management Systems (BMS).
Benefits
- 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).
