Technical Responsibilities:

• Ability to operate advanced HMI applications.
• Perform basic level machine operation, set-up and troubleshooting of all state-of-the-art equipment in their area (may include Vial Washer, Depyrogenation Tunnel, Filling Machine, Isolator, Stopper Loading Systems, Capping Machine, Glove Tester, Automatic Loading & Unloading System (ALUS), Lyophilizers, Parts Washers, Component Sterilizers, Stopper Cans, Filter Integrity Tester, Vaporized Hydrogen Peroxide Transfer Hatch) to meet process parameters
• Load Parts Washer, Component Sterilizer, Vial Washer, Filling Machine and Capping Machine with raw materials and format parts
• Practices and understands aseptic manufacturing principles  Maintains gown qualification if required by their area
• Perform microbiological monitoring within the Filling Machine, ALUS, and Capping Machine
• Assist other departments including MQA, Maintenance, Metrology, Engineering, Validation, Tech Transfer and Microbiology, with tasks on the equipment in their area

General Responsibilities:

• Clean and sanitize equipment and Production areas per SOP
• Transfer raw materials, operating supplies, and finished product in and out of the manufacturing areas
• Multi-task and learn multiple manufacturing areas
• Train and comply with current SOPs and GMPs
• Documents work accurately and timely
• Understand the process flow and step by step requirements for manufacturing
• Work in a time efficient manner while maintaining adherence to all applicable SOPs
• Concise communication with co-workers and managers to promote a teamwork atmosphere
• Perform other duties as directed
• All employees are responsible for ensuring compliance with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems as per your roles and responsibilities

Requirements:

• Have a minimum of a High School Diploma, GED, or equivalent education with one year of experience in a relevant work environment
• Able to work 12hr shifts on a 2-2-3 schedule
• Able to stand on concrete floors for an extended period of time
• Able to lift up to 35 pounds by bending and lifting
• Able to move heavy equipment and components as needed
• Able to work with hazardous materials including antineoplastic products and raw materials that could lead to serious illness/injury
• Able to wear required personal protective equipment (eye protection, safety shoes, gown, gloves)
• Must be able to understand, speak, and write English in order to comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals

The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.