Expert/Sr./Specialist- Environmental Monitoring and Microbiology

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.

Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.  The Quality Control Laboratory assures patients worldwide receive safe and efficacious drug and drug/device combination products through effective execution of product testing.

Position Description:

The Technician –Environmental Monitoring (EM) is responsible for providing utility and classified clean room monitoring support for LP2 Operations.  The technician is also responsible for performing routine and investigational monitoring of direct impact utilities in LP2 Operations and Support Areas.

Key Objectives/Deliverables:

• Support production operations by means of EM sampling of classified manufacturing, filling, and support areas and operations personnel
• Perform routine and investigational monitoring of direct impact utilities in LP2 Operations and Support Areas
• Execute Sample analysis on utilities Bioburden, Endotoxin, and Wet Chemistry
• Utilize sampling/testing equipment and supporting software and LIMS systems
• Ensures compliance with current Good Manufacturing Practices (GMP) and maintain constant inspection-readiness
• Ensures that data-integrity is maintained
• Participate in process streamlining and continuous performance improvement

Minimum Requirements:

• Knowledge of / familiarity with pharmaceutical production environments and operations
• Strong computer skills, documentation skills, and attention to detail
• Maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

Additional Preferences:

• Experience in Aseptic manufacturing or production, QC, QA, Technical Services, or Regulatory is desirable
• Technical writing and written communication skills
• Strong understanding of regulatory standards/requirements for EM

Education Requirements:

• Bachelor's degree in a relevant field (Biology, Microbiology, Chemistry, etc.)
  - or -
• Associate’s degree in a relevant field with 2+ years of experience (Environmental monitoring, Pharmaceutical Manufacturing, Quality Control laboratory, etc.)
  - or -
• High school diploma or equivalent with 4+ years of relevant experience (Environmental monitoring, Pharmaceutical Manufacturing, Quality Control laboratory, etc.)

Other Information:

• Ability to lift 30 lbs/ be able to pass push pull requirement for job duty
• Applicant may work in various areas within LP2.  Mobility requirements and exposure to allergens and or potentially hazardous utility systems should be considered when applying for this position
• EM Technician tasks involve repetitive motions
• EM Technician requires gowning certification, and repeatedly aseptically gown on a daily basis
• Must be able to stand / walk for extended periods of time
• Weekend/evening overtime may occur and will be determined based on a rotating schedule

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