Quality Control – Biologist/Microbiology

Industry:

Company: Eli Lilly and Company

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.

Position Brand Description:

The EM associate assists in the safe, compliant execution of the environmental monitoring (EM) program for the Research Triangle Park Facility for Lilly production areas (a 24/7 operation). This role is responsible for process monitoring and improvement, issue resolution/investigation, EM data system steward, and acts as a liaison between EM and multiple areas in ownership and/or execution of improvements, projects, and change controls.

Key Objectives/Deliverables:

• Ensure FUME and EM Programs meet or exceed agency guidelines.
• Provide technical guidance to Operations and other support areas regarding FUME and EM matters.
• Compile, review and approve FUME and EM evaluation reports and data review to support batch release.
• Provide technical support for FUME and EM initiatives involving viable, nonviable, personnel monitoring.
• Manage procedural revisions, if needed.
• Proactively drive FUME and EM projects that support operations, sterility assurance initiatives, and regulatory commitments.
• Perform root cause investigation of EM and/or FUME non-conformances.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Minimum Requirements:

• Bachelor degree in microbiology or related science
• 3 years of experience in a GMP pharmaceutical laboratory

Additional Preferences:

• Strong understanding of current internal and applicable external standards for FUME, EM and sterility assurance.
• Problem solving and decision-making skills, with emphasis on data-based decisions, and customer service.
• Strong technical writing skills and proficiency in technical review of documents.
• Experience (3+ years) in Environmental Monitoring and/or Utilities Monitoring.
• Experience with MODA
• Experience with data trending and analysis.
• Experience with Root Cause Analysis

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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