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

Nature and Scope

This position is a member of the Manufacturing Team, responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Component Prep, Sanitization and Sterilization Technician II will participate in all aspects of the component and equipment prep process including sanitization of controlled manufacturing areas and post terminal sterilization.

Essential Duties and 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 SOPs and protocols.
• Provides feedback to supervisor and peers about cycle status, equipment condition, and other issues affecting the production schedule or continuous improvement.
• Cleans all manufacturing areas.
• Executes tasks and works in a clean room environment.
• Prepares solutions and dilutions.
• Handles materials using pallet jacks and power industrial trucks.
• Performs tray transfer and de-boxing.
• Performs autoclave daily and weekly tests including system checks.
• Prepares materials, equipment, and components for autoclaving.
• Generates component autoclave labels using work templates.
• Demonstrates proficiency in load patterns and cycle parameters for steam and dry heat sterilizers.
• Loads and unloads sterilizers.
• Requisitions and receives equipment and area logbooks.
• Performs mobility scanning of all materials in BPCS.
• Performs filter testing using automated testing equipment.
• Operates autoclaves and terminal sterilizers.
• Troubleshoots sterilization and filtration equipment.
• Trains and mentors Level I Component Prep Sanitization employees.
• Performs any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• High School Diploma or GED required.
• At least one year as a Component Prep Sanitization and Sterilization Technician I, having performed at a satisfactory level, or two years similar work experience in a related field required.
• 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. PPE and respirators are essential for the health and safety of employees. Employee must be able to occasionally lift and/or move up to 50 pounds.