Sterilization Technician I (6 am-2:30 pm)
American Regent, Inc.
About the Role
This entry-level position is part of the Manufacturing Team, responsible for manufacturing safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies, and cGMPs. The team ensures aseptic and sanitary conditions, accurate batch records, and professional behavior. The Sterilization Technician I will participate in all aspects of the component and equipment prep process, including sanitization of controlled manufacturing areas and post-terminal sterilization.
Key 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, and batch records per quality and cGMP requirements.
- Ensures strict adherence to and compliance with SOPs and protocols.
- Ensures all work is performed and documented in accordance with existing company policies, procedures (SOPs), 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.
- Cleans all manufacturing areas.
- Gains knowledge of batch records and processes.
- Participates in cGMP Compliance.
- Executes tasks and works in a cleanroom environment.
- Prepares solutions and dilutions.
- Performs material handling using pallet jacks and power industrial trucks.
- Performs Tray Transfer.
- Performs De-boxing.
- Conducts Autoclave daily and weekly tests including system checks.
- Prepares materials, equipment, and components for autoclaving.
- Generates component autoclave labels using work templates.
- Understands load patterns and cycle parameters for steam and dry heat sterilizers.
- Loads and unloads sterilizers.
- Requisitions and receives equipment and area logbooks.
- Performs any other tasks/duties as assigned by management.
Requirements & Tech Stack
- High School Diploma or GED required.
- One year of working experience in a manufacturing production environment preferred.
- Ability to perform repetitive lifting, cleaning, and stacking activities.
- Mechanical aptitude preferred.
- 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.
Physical Environment and Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
- Employee must be able to occasionally lift and/or move up to 50 pounds.