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

About the role

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 a 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.

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