About The Position

Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Concord, North Carolina. 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. This position will provide support for Parenteral Operations by performing environmental monitoring of the classified manufacturing areas and by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings. The QC Expert Environmental Monitoring Technician will assist the QC Environmental Monitoring management with training other QC Environmental Monitoring Technicians and providing support in the manufacturing areas during routine environmental monitoring and utility sampling.

Requirements

  • High School Diploma or equivalent
  • 2+ years of demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production.
  • Demonstrated ability in performing environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water (potable, purified water, water for injection, clean steam) collection and analysis.
  • Previous experience with Laboratory IT systems such as LIMs, LES, and MODA.
  • Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
  • Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
  • 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

  • Associate Degree is preferred.
  • Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
  • Strong interpersonal skills and ability to train/mentor QC Environmental Monitoring Technicians.
  • Strong oral and written communication skills for communicating to colleagues, management, and other departments.

Responsibilities

  • Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices.
  • Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
  • Provide support for manufacturing and laboratory activities by performing utility sampling and analysis within the Parenteral Operations and QC Laboratory buildings.
  • Assist with technical training and mentoring of QC Environmental Monitoring Technicians through formal process/program.
  • Participate in department/company continuous improvement projects and initiatives.
  • Assist with authoring Standard Operating Procedures and Work Instruction documentation.
  • Adhere to and promote compliance of all safety standards.

Benefits

  • company bonus (depending, in part, on company and individual performance)
  • company-sponsored 401(k)
  • pension
  • vacation benefits
  • 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
  • well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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