Sterilization Technician I (6 am-2:30 pm)

American Regent, Inc.; New Albany, Northern (OH, KY); Hybrid; USD 35,000 - 45,000; Full time

Job summary

American Regent, Inc. in New Albany, OH is seeking an Entry Level Component Prep, Sanitization and Sterilization Technician I to join the Manufacturing Team. The role focuses on aseptic processing, cleaning, sterilization, and batch documentation in a compliant cGMP environment.

You will support prep, sanitization, and sterilization activities under supervision, participate in batch records, and help maintain production schedules while adhering to safety and quality standards.

Qualifications

• High School Diploma or GED required.
• 1 year working experience in a manufacturing production environment preferred.
• Ability to perform repetitive lifting, cleaning, and stacking activities.

Responsibilities

• Performs sanitary cleaning activities as defined by SOPs and directed by Manager/Supervisor.
• Performs production prep activities including deboxing, staging, sterilization and post-fill sterilization.
• Completes production documentation including logbooks, batch records, and cleaning tags per quality and cGMP requirements.
• Ensures adherence to SOPs and protocols and health and safety requirements.
• Assists with tasks to maintain production schedules and support continuous improvement.

Skills

Attention to detail

Team collaboration

Manual dexterity

Education

High School Diploma or GED

Job description

Nature and Scope

This entry level 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 I 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. 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

• 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
• Gain the Knowledge 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
• Understanding load patterns and cycle parameters for steam and dry heat sterilizers
• Loading and unloading sterilizers
• Requisitioning and receiving equipment and area logbooks
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• High School Diploma or GED required.
• One year 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. 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. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.

Equal Opportunity and Diversity

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.

Company Culture and Values

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. 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. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.