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Form of workAt 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 Environmental Monitoring Technician will perform routine and investigational Environmental Monitoring of classified manufacturing, filling, and support areas. Support daily EM laboratory operations.
Responsibilities:
- Support production operations by means of EM sampling of classified manufacturing, filling, and support areas and operations personnel.
- Support daily EM laboratory operations and process/equipment qualification activities, as necessary.
- Ensures compliance with current Good Manufacturing Practice (cGMP) and maintain constant inspection-readiness.
- Ensures that data-integrity is maintained
- Participate in process streamlining and continuous performance improvement.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
- EM Technician requires gowning certification, and repeatedly aseptically gown daily.
Basic Requirements:
- High School Diploma or equivalent, Associates degree preferred.
- Understanding of cGMP
- Excellent written and oral communication skills and ability to collaborate and interact with a team.
- Work in a dynamic and fast paced environment with potential to work shifts and weekends.
- Must be able to lift 30 pounds and be able to pass, push, and pull to execute specific aspects of job duty.
- Must be able to stand / walk for extended periods of time.
Additional Preferences:
- Environmental Monitoring experience preferred.
- Manufacturing or production experience preferred.
- Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.
- Technical writing and written communication skills are a plus.
- Understanding of regulatory standards / requirements for EM.
- Knowledge of / familiarity with Parenteral production environments and operations.
- Strong computer skills, documentation skills, and attention to detail.
- Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Corporate and Site Goals.
- Ability to focus on continuous improvement.
- Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.
- Understanding of compliance requirements and regulatory expectations for lab systems.
Additional Information:
- Minimal travel required
- Some allergens are present in the parenteral plant.
- Position will start on days shifts before transitioning to Night Shift.
- 12 hour shifts on 2-2-3 schedule. 6PM - 6AM
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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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.
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