Environmental Monitoring Supervisor

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

Position Description: Lilly is a fortune 500 company in operation for over 146 years creating high-quality medicines for our patients while living our company values of Integrity, Excellence, and Respect for People in everything that we do.

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 Supervisor will provide supervision for a shift of Environmental Monitoring (EM) Technicians to ensure compliant customer service to Parenteral Plant production operations. Assist in performing routine environmental monitoring of aseptic manufacturing, filling, and supporting areas. Provide EM technical support to production and other areas within the plant.

The shift will be a 2-3-3-2 structure with hours of 0600-1800 or 1800-0600.

Key Objectives/Deliverables:

• Enforce compliance to all procedures, methods, and other regulatory commitments as relating to EM, as well as applicable production operations.
• Comply with cGMP and ensure that the integrity of the data collected is maintained.
• Ensure department compliance with EM Quality Systems, cGMP, and Good Documentation Practice with appropriate escalation of issues to management.
• Assist in routine environmental 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.
• EM Supervisor requires gowning certification, and repeatedly aseptically gown daily.

Requirements (Education, Experience, Training):

• Minimum 4 years of experience in Environmental Monitoring
• Associate degree OR High School Diploma/GED with 4+ years of additional experience
• High degree of understanding of cGMP required.
• 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.

Preferred attributes but not required:

• Previous Environmental Monitoring Supervisor experience preferred.
• Bachelor's Degree preferred.
• Manufacturing or production experience preferred.
• Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable.
• 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. Previous experience with laboratory IT systems including LIMS, LES, and standalone COTS systems.
• 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.
• Ability to focus on continuous improvement.
• Technical writing and written communication skills are a plus.
• CAPA Lead Investigator - Root Cause Analysis certification.

Other Information:

• Position is for the RTP site located in Durham, NC
• Minimal travel required
• Some allergens are present in the parenteral plant
• EM Supervisor tasks involve repetitive motions.
• The shift will be a 2-3-3-2 structure with hours of 0600-1800 or 1800-0600.

This 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. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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.

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.

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