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

americanregent; New Albany (OH); On-site; USD 40,000 - 60,000; Full time

Job summary

American Regent is seeking a Component Prep Sanitization and Sterilization Technician II to join the Manufacturing Team in a sterile pharmaceutical production setting. You will assist with component prep, sanitization, and sterilization processes under supervision, ensuring clean room standards and compliance with cGMP and SOPs.

The role involves training junior staff, handling autoclave operations, and maintaining production documentation.

Qualifications

• High School Diploma or GED required.
• At least one year as a Component Prep Sanitization and Sterilization Technician I, or two years similar experience.
• Ability to perform repetitive lifting, cleaning, and stacking.
• Strong attention to detail and organization skills.
• Excellent interpersonal and communication skills (oral and written).
• Must be able to read documents in Standard English.

Responsibilities

• Performs sanitary cleaning activities per established procedures and as directed by Supervisor/Manager.
• Performs production prep activities including deboxing, staging, equipment and component sterilization and post fill sterilization.
• Complete production documentation per quality and cGMP requirements.
• Ensure compliance with SOPs and health and safety requirements.
• Provide feedback on cycle status, equipment condition, and issues affecting production schedule.
• Clean all manufacturing areas.
• Operate autoclaves and terminal sterilizers; load/unload sterilizers.
• Train and mentor Level I Component Prep Sanitization employees.

Skills

Teamwork

Attention to detail

Communication skills

Mechanical aptitude

Basic math

Reading English documents

Education

High School Diploma or GED

Experience as Component Prep Sanitization and Sterilization Technician I or related field

Job description

Nature and Scope

This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area, equipment and batch records are neat and accurate and that safe, effective, and professional behavior is always displayed. The Component prep, Sanitization and Sterilization Technician II will be able to participate in all aspects of the component and equipment Prep Process including the sanitization of controlled manufacturing areas and post terminal sterilization. The Component Prep Process includes dispensing components (Caps and Seals), vial washing and component sterilization in accordance with established production records in a concentrated effort to manufacture sterile pharmaceuticals. The Sanitization of controlled areas plays critical role in assuring sanitary conditions of the controlled areas to manufacture sterile pharmaceuticals is maintained. The Team Member will assist with all activities associated with the component prep, sanitization, and sterilization process under the direct supervision of Senior Manufacturing Team Members. This Team Member will be proficient in all activities associated with the component prep, sterilization, and sanitization processes and will be able to work under minimal supervision. The Team Member will receive direction, training, and mentorship from the senior team members. Component prep, Sanitization and Sterilization Technician II will provide training to Component prep, Sanitization and Sterilization Technician I and be able to troubleshoot minor equipment adjustments and make repairs. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company Goals.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• 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.

Education Requirements and Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
• 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 Englis