Production Technician I (12-Hour Overnight 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 product contamination and uses advanced computerized systems through HMI applications. The position works 12-hour overnight shifts on a 2-2-3 schedule. The role involves operating, setting up, and troubleshooting equipment; loading equipment with raw materials and format parts; performing microbiological monitoring; cleaning and sanitizing equipment and production areas; and transferring materials and finished product. The technician may assist other departments with equipment-related tasks and must document work accurately, follow SOPs and GMPs, communicate effectively, and support a teamwork atmosphere. Employees are also responsible for compliance with applicable Health, Safety, Environment, Energy, and Quality Management Systems. The position requires a high school diploma, GED, or equivalent education and one year of experience in a relevant work environment. It involves extended standing on concrete floors, lifting up to 35 pounds, moving heavy equipment and components, handling hazardous materials including antineoplastic products, and wearing required personal protective equipment. English proficiency is required to understand and follow workplace policies, procedures, training materials, and communications.

Requirements

High school diploma, GED, or equivalent education.
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 cause 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, and other manuals.

Responsibilities

Assemble, operate, and monitor aseptic equipment in accordance with applicable SOPs and current GMPs.
Apply aseptic manufacturing techniques to minimize the potential for product contamination.
Operate advanced HMI applications.
Perform basic machine operation, setup, and troubleshooting for equipment in the assigned area to meet process parameters.
Load Parts Washer, Component Sterilizer, Vial Washer, Filling Machine, and Capping Machine with raw materials and format parts.
Maintain gown qualification if required by 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 product 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 the process flow and step-by-step manufacturing requirements.
Work efficiently while adhering to applicable SOPs.
Communicate concisely with coworkers and managers to promote teamwork.
Perform other duties as directed.
Ensure compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.