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

American Regent, Inc.•New Albany, OH

About The Position

This position is a member of the Manufacturing Team, which manufactures 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. Component preparation includes dispensing caps and seals, vial washing, and sterilizing components according to production records. The role supports sanitary conditions in controlled areas and performs these activities under the direction of senior Manufacturing Team members. The Technician II is proficient in component preparation, sterilization, and sanitization and can work with minimal supervision. The position also trains Component Prep Sanitization and Sterilization Technician I employees, troubleshoots minor equipment issues, and makes repairs. The Manufacturing Team collaborates with Production Management and other departments to support production schedules and company goals.

Requirements

High school diploma or GED.
At least one year as a Component Prep Sanitization and Sterilization Technician I with satisfactory performance, or two years of similar work experience in a related field.
Ability to perform repetitive lifting, cleaning, and stacking activities.
Ability to perform basic arithmetic, including calculations of averages and percentages.
Strong attention to detail or organizational skills.
Excellent oral and written interpersonal and communication skills.
Demonstrated success working 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

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, cGMPs, and health and safety requirements.
Provide feedback to supervisors and peers about cycle status, equipment condition, production schedule-impacting issues, and continuous improvement.
Clean manufacturing areas and work in a cleanroom environment.
Prepare solutions and dilutions.
Handle materials using pallet jacks and power industrial trucks; perform tray transfers and deboxing.
Conduct daily and weekly autoclave tests, including system checks.
Prepare materials, equipment, and components for autoclaving; generate component autoclave labels using work templates.
Apply knowledge of load patterns and cycle parameters for steam and dry heat sterilizers; load and unload sterilizers.
Requisition and receive equipment and area logbooks.
Mobility-scan materials in BPCS.
Perform filter testing using automated testing equipment.
Operate autoclaves and terminal sterilizers; troubleshoot sterilization and filtration equipment.
Train and mentor Level I Component Prep Sanitization employees.
Perform other tasks and duties assigned by management.