Job DetailsAt 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.
Company Overview:At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Organization Overview:Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.
What You'll Be Doing:The QC Environmental Monitoring Supervisor will provide oversight and supervision of the QC Environmental Monitoring Technicians. The QC Environmental Monitoring Supervisor will coordinate environmental monitoring activities to be performed in support of Parenteral Operations and routine facility monitoring requirements. Additionally, the QC Environmental Monitoring Supervisor will assist in training QC Environmental Monitoring Technicians and will provide alternate support in performing environmental monitoring activities as required.
Key Objectives/Deliverables:- Ensure and enforce compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
- Provide supervision and oversight of the QC Environmental Monitoring Technicians during the day-to-day activities, including any non-routine day-to-day activities (i.e., Media Fills, EM PQs) that may arise based on production needs.
- Coordinate environmental monitoring activities and assign job responsibilities to QC Environmental Monitoring Technician(s).
- Perform technical training and mentor QC Environmental Monitoring Technicians through formal process/program.
- Provide alternate support in assisting with routine or non-routine environmental monitoring activities as required.
- Provide shift support for QC Environmental Monitoring Technicians when non-routine events occur and escalate to management as required.
- Author and review Standard Operating Procedures, Work Instructions/Tools, and assist with development of the QC Environmental Monitoring Technician's Learning and Development (Training) Plans.
- Facilitate development for all direct reports, including but is not limited to coaching/mentoring of QC Environmental Monitoring Technicians, establishing goals, and providing performance improvement and performance recognition feedback.
- Comply with and assist in implementing safety standards.
- Support internal and external audits when necessary.
- Support EM investigations (excursions, nonconformance) as needed.
Minimum Requirements:- Associate degree or equivalent, Bachelor's (4-year) degree in a science related field is preferred.
Additional Preferences:- 4+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
- 1-2 plus years supervisory experience preferred.
- Experience in environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis.
- Experience with Laboratory IT systems such as LIMs, LES, and MODA.
- High level of experience with cGMP requirements, compliance, and regulatory guidance associated with a cGMP Pharmaceutical Manufacturing facility.
- Ability to focus on continuous improvement.
- Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
- Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
Additional Information: - During the project phase the working schedule will vary (typically M-F 8 hours). In operation, must have ability to work 12-hour night shift (2-2-3 structure).
- Travel will be required during the project phase for training and implementation of the Environmental Monitoring Program for the Concord site.
- This position may require a short-term assignment to train, be certified on existing processes, and establish key contacts.
- Tasks may require repetitive motion and standing or walking for long periods of time.
- Tasks may require lifting of up to 30 pounds and may require the ability to pass, push, and pull to execute specific aspects of the job role.
The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification.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 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