Production Technician I (12-Hour Overnight Shifts)

Fresenius Kabi USA•Melrose Park, IL

9d•Onsite

About The Position

The Production Technician I will be responsible for assembling, operating, and monitoring state-of-the-art, aseptic equipment following applicable Standard Operating Procedures and current Good Manufacturing Practices. This role requires knowledge of and practice of good aseptic techniques to minimize the potential for product contamination, as well as understanding advanced computerized systems through HMI. The technician will also be responsible for cleaning and sanitizing equipment and production areas, transferring raw materials and finished product, multi-tasking across manufacturing areas, training and complying with SOPs and GMPs, and accurately documenting work. A strong understanding of process flow and step-by-step manufacturing requirements is essential, along with efficient work habits and clear communication with colleagues and managers to foster teamwork. This is a 12-hour overnight shift position with a 2-2-3 schedule.

Requirements

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.

Responsibilities

Assembling, operating, and monitoring state-of-the-art, aseptic equipment following applicable Standard Operating Procedures and current Good Manufacturing Practices.
Practicing good aseptic techniques to minimize the potential for product contamination.
Understanding advanced computerized systems through HMI.
Operating advanced HMI applications.
Performing 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.
Loading Parts Washer, Component Sterilizer, Vial Washer, Filling Machine and Capping Machine with raw materials and format parts.
Practicing and understanding aseptic manufacturing principles.
Maintaining gown qualification if required by their area.
Performing microbiological monitoring within the Filling Machine, ALUS, and Capping Machine.
Assisting other departments including MQA, Maintenance, Metrology, Engineering, Validation, Tech Transfer and Microbiology, with tasks on the equipment in their area.
Cleaning and sanitizing equipment and Production areas per SOP.
Transferring raw materials, operating supplies, and finished product in and out of the manufacturing areas.
Multi-tasking and learning multiple manufacturing areas.
Training and complying with current SOPs and GMPs.
Documenting work accurately and timely.
Understanding the process flow and step by step requirements for manufacturing.
Working in a time efficient manner while maintaining adherence to all applicable SOPs.
Communicating concisely with co-workers and managers to promote a teamwork atmosphere.
Performing other duties as directed.
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.