Sterilization Technican II (6 am-2:30 pm)

American Regent, Inc. • New Albany, OH

2d • Onsite

About The Position

This 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 Component Prep, Sanitization and Sterilization Technician II participates in all aspects of the component and equipment prep process, including sanitization of controlled manufacturing areas and post-terminal sterilization. This includes dispensing components, vial washing, and component sterilization. The role also involves sanitizing controlled areas to maintain sanitary conditions for sterile pharmaceutical manufacturing. The Team Member assists with all activities associated with component prep, sanitization, and sterilization under direct supervision, and will become proficient to work with minimal supervision. They will receive training and mentorship from senior team members, provide training to Technician I, and troubleshoot minor equipment adjustments and repairs. The Manufacturing Team also provides input and assistance to other departments to maintain production schedules and meet company goals.

Requirements

• 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.
• 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

• 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.
• Complete production documentation including logbooks, cleaning tags, batch records, etc. per quality and cGMP requirements.
• Ensure strict adherence to and compliance with SOP’s and protocols.
• Ensure 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.
• Knowledgeable 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.
• Proficient in load patterns and cycle parameters for steam and dry heat sterilizers.
• Loading and unloading sterilizers.
• Requisitioning and receiving equipment and area logbooks.
• Mobility scanning of all materials in BPCS.
• Filter testing using automated testing equipment.
• Operation of Autoclaves and Terminal Sterilizers.
• Trouble shooting sterilization and filtration equipment.
• To be able to train and mentor Level I Component Prep Sanitization employees.
• 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.
• We have locations in New York, Ohio, and California and sales territories nationwide.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED