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.
CEMS Lead Technician
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.
Main Purpose and Objectives of Position:
The CEMS (Continuous Emission Monitoring System) Lead Tech. is part of the LP1 maintenance organization working closely with the Health, Safety, and Environmental (HSE) team and provides technical leadership and expertise in the development, implementation, and maintenance of CEMS. This role requires significant collaboration, creativity, and resilience to ensure compliance with environmental regulations and to minimize emissions from industrial facilities. This role ensures that all CEMS systems operate efficiently and comply with regulatory standards to maintain a controlled environment for pharmaceutical production. The CEMS Lead will be instrumental in the development of the CEMS management system and development of others responsible for maintaining the equipment.
Key Responsibilities:
Safety: 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.
Quality: Responsible for compliance and meeting the quality standards as defined by cGMPs, the Global Quality Standards, local procedures
CEMS Program Management:
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 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.
Develop People Effectively: 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, to assist with operational issues, development, planning, and reporting of results.
New Site Startup:
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. Participate in Project and best practice initiatives within the Maintenance, Engineering, and Facility teams.
Basic 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.
Additional Preferences:
Additional Information:
Tasks require entering manufacturing areas which require wearing appropriate PPE.
May be required to provide support outside of normal working hours including nights, weekends, and holidays.
Travel to other facilities within the Lilly network (Minimal)
With this being a green site. Development of the CEMS program will take place with a transition to maintaining the CEMS system. This role very likely could transform and change and or be placed within another organization at this site in the future.
New site operational readiness will focus on development of the CEMS program and will transition to maintaining the CEMS program. Over time, this role may transform as CEMS capability is enhanced at the site.
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Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$31.37 - $52.28
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.