Production Technician I (12-Hour Day Shift)

Fresenius Kabi USA•Melrose Park, IL

About The Position

The Production Technician I assembles, operates, and monitors state-of-the-art aseptic equipment in accordance with applicable Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (GMPs). The technician applies aseptic techniques to minimize the potential for product contamination and uses advanced computerized systems through HMI. The role includes operating, setting up, and performing basic troubleshooting on equipment; loading equipment with raw materials and format parts; conducting microbiological monitoring; and maintaining gown qualification where required. The technician also cleans and sanitizes equipment and production areas, transfers materials and finished product, documents work, learns multiple manufacturing areas, and collaborates with other departments on equipment-related tasks. The position follows a 12-hour shift on a 2-2-3 schedule. It requires standing for extended periods on concrete floors, lifting up to 35 pounds, moving heavy equipment and components as needed, working with hazardous materials, and wearing required personal protective equipment. English proficiency is required to understand and comply with procedures, training materials, and workplace communications.

Requirements

High school diploma, GED, or equivalent education.
At least one year of experience in a relevant work environment.
Ability to work 12-hour shifts on a 2-2-3 schedule.
Ability to stand on concrete floors for extended periods.
Ability to lift up to 35 pounds by bending and lifting.
Ability to move heavy equipment and components as needed.
Ability to work with hazardous materials, including antineoplastic products and raw materials that could lead to serious illness or injury.
Ability to wear required personal protective equipment, including eye protection, safety shoes, gown, and gloves.
Ability to understand, speak, and write English to comply with SOPs, specifications, job-specific training materials, GMPs, manuals, and workplace communications.

Responsibilities

Assemble, operate, and monitor aseptic equipment according to applicable SOPs and current GMPs.
Operate advanced HMI applications.
Perform basic machine operation, setup, and troubleshooting on equipment in the assigned area to meet process parameters.
Load parts washers, component sterilizers, vial washers, filling machines, and capping machines with raw materials and format parts.
Practice aseptic manufacturing principles and maintain gown qualification if required in the assigned area.
Perform microbiological monitoring within the Filling Machine, ALUS, and Capping Machine.
Assist MQA, Maintenance, Metrology, Engineering, Validation, Tech Transfer, and Microbiology with tasks involving equipment in the assigned area.
Clean and sanitize equipment and production areas according to SOPs.
Transfer raw materials, operating supplies, and finished products into and out of manufacturing areas.
Learn and work in multiple manufacturing areas.
Train and comply with current SOPs and GMPs.
Document work accurately and promptly.
Understand manufacturing process flow and step-by-step requirements.
Work efficiently while adhering to applicable SOPs.
Communicate concisely with coworkers and managers to support teamwork.
Perform other duties as directed.
Ensure compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, as applicable to the role.