Production Technician I (12-Hour Overnight Shift)

Fresenius Kabi•Melrose Park, IL

About The Position

The Production Technician I assembles, operates, and monitors aseptic manufacturing equipment in accordance with applicable Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (GMPs). The technician practices aseptic techniques to minimize product contamination and uses advanced computerized systems through HMI. Work includes operating and troubleshooting equipment, handling materials, maintaining clean production areas, documenting work, and supporting related departments. The role requires working 12-hour shifts on a 2-2-3 schedule and may involve gown qualification, microbiological monitoring, hazardous materials, and required personal protective equipment.

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 cause serious illness or injury.
Ability to wear required personal protective equipment, including eye protection, safety shoes, gown, and gloves.
Ability to effectively speak, read, write, and understand English to follow SOPs, specifications, job-specific training materials, GMPs, manuals, policies, procedures, and workplace communications.

Responsibilities

Operate advanced HMI applications.
Perform basic machine operation, setup, and troubleshooting on equipment in the assigned area, including equipment such as vial washers, depyrogenation tunnels, filling machines, isolators, stopper loading systems, capping machines, glove testers, ALUS, lyophilizers, parts washers, component sterilizers, stopper cans, filter integrity testers, and vaporized hydrogen peroxide transfer hatches.
Load parts washers, component sterilizers, vial washers, filling machines, and capping machines with raw materials and format parts.
Practice and apply aseptic manufacturing principles.
Maintain gown qualification if required by the assigned area.
Perform microbiological monitoring within the filling machine, ALUS, and capping machine.
Assist departments including 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 across multiple manufacturing areas.
Train on 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 clearly 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, consistent with assigned responsibilities.