Sterilization Technician I (1:30 pm-10 pm)

American Regent, Inc.Hilliard, OH
Onsite

About The Position

This entry-level position is a member of the Manufacturing Team, responsible for manufacturing safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role ensures aseptic and sanitary conditions are maintained, that manufacturing areas, equipment, and batch records are accurate, and that professional behavior is displayed. The technician will participate in all aspects of component and equipment preparation, including sanitization of controlled manufacturing areas and post-terminal sterilization. This includes dispensing components (Caps and Seals), vial washing, and component sterilization. Sanitization of controlled areas is critical for maintaining sanitary conditions. The team member will assist with all activities under the direct supervision of Senior Manufacturing Team Members and provide input to other departments to meet production schedules and company goals.

Requirements

  • High School Diploma or GED required.
  • Ability to perform repetitive lifting, cleaning, and stacking activities.
  • Ability to perform basic math including addition, subtraction, multiplication, division and calculations of averages and percentages.
  • Strong attention to detail or organization skills.
  • Excellent interpersonal and communication skills (oral and written).
  • Demonstrated success working in a team environment.
  • Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
  • Ability to work overtime as needed.

Nice To Haves

  • One year working experience in a manufacturing production environment preferred.
  • Mechanical aptitude preferred.

Responsibilities

  • Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor.
  • Performs a variety of production prep activities including deboxing, staging, equipment and component sterilization and post fill sterilization.
  • Completes production documentation including logbooks, cleaning tags, batch records, etc. per quality and cGMP requirements.
  • Ensures strict adherence to and compliance with SOP’s and protocols.
  • Ensures all work is performed and documented in accordance with existing company policies, procedures (SOP’s), Current Good Manufacturing Practices (cGMPs), and health and safety requirements.
  • Provides feedback to supervisor and peers about cycle status, equipment condition, and other issues that would affect the production schedule or relate to continuous improvement.
  • Cleaning of all manufacturing areas
  • Gain the Knowledge of batch records and processes
  • cGMP Compliance
  • Execution of tasks and working in a clean room environment
  • Preparation of solutions and dilutions
  • Material handling using pallet jacks and power industrial trucks
  • Tray Transfer
  • De-boxing
  • Autoclave daily and weekly test including system checks
  • Preparation of materials, equipment, and components for autoclaving
  • Generation of component autoclave labels using work templates
  • Understanding load patterns and cycle parameters for steam and dry heat sterilizers
  • Loading and unloading sterilizers
  • Requisitioning and receiving equipment and area logbooks
  • Perform any other tasks/duties as assigned by management.

Benefits

  • Supporting patient health and enhancing the quality of life for animals are our guiding principles.
  • Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables.
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