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Environmental Monitoring Technician - Day Shift

BioSpace
Durham, KSA
Full Time
Entry
Onsite
3 weeks ago
Environmental MonitoringcGMPAseptic TechniqueData IntegrityLIMSTechnical Writing
Free

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Environmental MonitoringcGMPAseptic Technique
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Organization Overview

  • Lilly is designing and building a new state of the art Parenteral, Device, and Packaging Assembly Facility in Raleigh Durham, NC.
  • The QC Environmental Monitoring Technician will perform routine and investigational environmental monitoring of classified areas.

Responsibilities

  • Support production operations by EM sampling of classified manufacturing, filling, and support areas and personnel.
  • Support daily EM laboratory operations and process/equipment qualification activities.
  • Ensure compliance with cGMP and maintain constant inspection readiness.
  • Ensure data integrity is maintained; participate in process streamlining and continuous improvement.
  • Maintain a safe work environment; requires gowning certification and daily aseptic gowning.

Basic Requirements

  • High School Diploma or equivalent; Associates degree preferred.
  • Environmental Monitoring experience preferred; manufacturing or production experience preferred.
  • Experience in aseptic manufacturing, QC, QA, Technical Services, or Regulatory desirable.
  • Technical writing and written communication skills a plus.
  • Understanding of regulatory standards/requirements for EM; knowledge of parenteral production environments.
  • Strong computer skills, documentation skills, and attention to detail.
  • Ability to focus on continuous improvement.
  • Previous experience with laboratory IT systems including LIMS, LES, and COTS systems.
  • Understanding of cGMP; excellent communication and collaboration skills.
  • Ability to work in a dynamic fast paced environment with potential shifts and weekends.

Additional Information

  • Must be able to lift 30 pounds and stand/walk for extended periods.
  • Minimal travel required; some allergens present in the parenteral plant.
  • Position starts on day shifts then transitions to 12 hour shifts on 2 2 3 schedule (6am 6:30pm).
  • Qualified applicants must be authorized to work in the US; no visa sponsorship.

Compensation

  • Anticipated wage range: $18.02 $34.90 per hour.
  • Full time employees eligible for company bonus, 401(k), pension, vacation, medical/dental/vision, and other benefits.

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