Summary

The FreeFlex Bag Filling Operators I are responsible for the cleaning, loading all the commodities, startup activities, perform in-process checks, and the normal operation of the batch. Additionally, they may be assigned tasks related to the general upkeep of the area, size change overs, setting up the line, and performing minor maintenance. All these activities are governed by strict procedures and regulations and require a high degree of training, as well as working under close supervision from the Production Supervisor. Therefore, Filling Operators I must complete all required training, and follow all applicable Standard Operating Procedures, Batch Records, and Protocols, and must be familiar with current Good Manufacturing Practices.

Job description

Job Summary

The FreeFlex Bag Filling Operators I are responsible for the cleaning, loading all the commodities, startup activities, perform in-process checks, and the normal operation of the batch. Additionally, they may be assigned tasks related to the general upkeep of the area, size change overs, setting up the line, and performing minor maintenance. All these activities are governed by strict procedures and regulations and require a high degree of training, as well as working under close supervision from the Production Supervisor. Therefore, Filling Operators I must complete all required training, and follow all applicable Standard Operating Procedures, Batch Records, and Protocols, and must be familiar with current Good Manufacturing Practices.

Responsibilities

Cleaning, loading all the commodities, startup activities, and the normal operation of the batch.
May perform minor maintenance and preventative maintenance of production lines.
Use of cleanroom behavior technique while in the classified areas to minimize potential for product contamination.
Learning to master the set-up of the filling equipment and operate and perform minor mechanical troubleshooting of a fully Integrated Bag Making Filling Machine (IBFM), Robot Cell Overwrap equipment (RCO) and Overwrap Machine, in a cleanroom environment, to ensure minimal downtime is encountered.
Perform peer to peer batch record documentation review throughout the shift to ensure documentation is accurate and in alignment to the Good Documentation Practice standards.
Required to operate advanced HMI applications.
Documenting work accurately and in a timely manner in the batch record and/or logbooks.
Adheres to SOP's, cGMP's, and Safety Requirements.
Performs "shadow" training of Filling Operators II and III.
Performs other duties as assigned by management.
Responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements

Familiarity with current Good Manufacturing Practices (cGMP)
Ability to follow Standard Operating Procedures, Batch Records, and Protocols
Ability to operate advanced HMI applications
Ability to perform minor mechanical troubleshooting
Cleanroom behavior technique
Accurate documentation skills
Adherence to safety requirements

Benefits

401(k) Matching
Paid Vacation
Holiday Pay
Personal Days
Employee Assistance Program
Medical, Dental & Vision
Prescription Drug Coverage
Life Insurance
Disability Insurance
Wellness Program

Company overview

Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.