Environmental Monitoring Supervisor (Night Shift)

Lilly

21d • $35 - $57 • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree