Sterilization Technician I (6 am-2:30 pm)

American Regent, Inc.•Hilliard, OH

About The Position

The Sterilization Technician I is an entry-level member of the Manufacturing Team, which supports the manufacture of safe, effective, sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The role participates in component and equipment preparation, sanitization of controlled manufacturing areas, and post-terminal sterilization, under the direct supervision of senior Manufacturing Team members. The position supports component preparation activities such as dispensing caps and seals, vial washing, and sterilizing components according to established production records. It also helps maintain sanitary conditions in controlled areas and contributes to production schedules and company goals in coordination with Production Management and other departments.

Requirements

  • High school diploma or GED.
  • Ability to perform repetitive lifting, cleaning, and stacking activities.
  • Ability to perform basic math, including arithmetic and calculations of averages and percentages.
  • Strong attention to detail or organizational skills.
  • Excellent oral and written interpersonal and communication skills.
  • Demonstrated ability to work successfully in a team environment.
  • Ability to read Standard English documents such as SOPs, maintenance schedules, and operating manuals.
  • Ability to work overtime as needed.
  • Ability to wear cleanroom and protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
  • Ability to occasionally lift and/or move up to 50 pounds.

Nice To Haves

  • One year of work experience in a manufacturing production environment.
  • Mechanical aptitude.

Responsibilities

  • Perform sanitary cleaning activities according to operating procedures and Manager or Supervisor direction.
  • Perform production preparation activities, including deboxing, staging, equipment and component sterilization, and post-fill sterilization.
  • Complete production documentation, including logbooks, cleaning tags, and batch records, in accordance with quality and cGMP requirements.
  • Follow SOPs, protocols, company policies and procedures, cGMPs, and health and safety requirements.
  • Update supervisors and peers on cycle status, equipment condition, and other issues affecting production schedules or continuous improvement.
  • Clean manufacturing areas.
  • Learn batch records and processes.
  • Execute tasks in a cleanroom environment.
  • Prepare solutions and dilutions.
  • Handle materials using pallet jacks and power industrial trucks.
  • Transfer trays and de-box materials.
  • Perform daily and weekly autoclave tests, including system checks.
  • Prepare materials, equipment, and components for autoclaving.
  • Generate component autoclave labels using work templates.
  • Understand load patterns and cycle parameters for steam and dry heat sterilizers.
  • Load and unload sterilizers.
  • Request and receive equipment and area logbooks.
  • Perform other tasks and duties as assigned by management.
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