Environmental Monitoring Supervisor; Night Shift

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.

The Environmental Monitoring Supervisor (Night Shift) 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.

• 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.
• 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.
• 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.
• Qualified applicants must be authorized to work in the United States on a full‑time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F‑1 CPT, F‑1 OPT, F‑1 STEM OPT, J‑1, H‑1B, TN, O‑1, E‑3, H‑1B1, or L‑1.

• 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.
• Position is in support of a 24/7 manufacturing operation. On call support outside of designated shift may be required.
• 12 hour shifts on 2‑2‑3, second shift schedule

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