Environmental Monitoring Supervisor

2 weeks ago

Durham, North Carolina, United States Eli Lilly and Company 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 is designing and building a new state of the art Parenteral, Device, and Packaging Assembly 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 QC EM Supervisor will provide supervision for a shift of Environmental Monitoring (EM) Technicians to ensure compliant customer service to RTP Plant production operations. Assist in performing routine environmental and utility monitoring of aseptic manufacturing, filling, and supporting areas. Provide EM technical support to production and other areas within the plant.

Key Objectives/Deliverables:

Enforce compliance to all procedures, methods, and other regulatory commitments as relating to EM/UM, as well as applicable production operations.Comply with cGMPs and ensure that the integrity of the data collected is maintained.Ensure department compliance with EM Quality Systems, cGMPs, and Good Documentation Practices with appropriate escalation of issues to management.Assist in routine environmental monitoring/utility monitoring of all production areas, as well as (where applicable) viable monitoring of personnel.Proactively manage daily business to meet customer requirements to include workload management and shift communication.Develop Performance Management (PM) for employees, coach and provide feedback for performance improvement, and recognize both performance accomplishments and gaps.Provide shift-support on issues and electronic-disposition of area- and equipment-HOLDs based on EM data.Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.Minimum Requirements:High School Diploma or GED4+ years of experience in Environmental Monitoring (Supervisor experience preferred).Experience working in GMP environmentAdditional Preferences:Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.Understanding of regulatory standards / requirements for EM/UM.Knowledge of / familiarity with Parenteral production environments and operations.Strong computer skills, documentation skills, and attention to detail. Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.Ability to focus on continuous improvement.Understanding of compliance requirements and regulatory expectations for lab systems.Excellent interpersonal skills to include proven and demonstrated teaching / coaching skills.Strong understanding of environmental monitoring and supported production or lab operations.Familiar with all related manufacturing areas within areas of responsibility and the associated environmental monitoring of those areas.Technical writing and written communication skills are a plus.CAPA Lead Investigator - Root Cause Analysis certification.Other Information: Minimal travel required.Position is M-F Night ShiftFlexible schedule: Position may require training or working on day shift for a short duration prior to transitioning to night shift. Weekend work may be required. Ability to work 12-hour shifts.Must be able to lift 30 pounds and be able to pass, push, and pull to execute specific aspects of job duty.EM Supervisor tasks involve repetitive motions.EM Supervisor requires gowning certification, and repeatedly aseptically gown daily.Must be able to stand / walk for extended periods of time.Ability to work in various areas within the site. Some allergens are present in the parenteral plant.Must pass a vision exam and be free of color blindnessMust be equivalent to 20/20 correctable close vision acuity 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 ( ) 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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