Filling Operator II

Fresenius Kabi USA•Wilson, NC

2d•$16 - $23•Onsite

About The Position

The FreeFlex Bag Filling Operators II are responsible for the cleaning, loading all the commodities, setup, size changeover, startup activities, perform in-process checks, performing minor maintenance, and the normal operation of the batch. Additionally, they may be assigned tasks related to the general upkeep of the area 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 moderate supervision from the Production Supervisor. Therefore, Filling Operators II 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.

Requirements

Must complete all required training.
Must follow all applicable Standard Operating Procedures, Batch Records, and Protocols.
Must be familiar with current Good Manufacturing Practices.
Must be adept at problem solving.
Must be able to operate advanced HMI applications.
Must use cleanroom behavior technique while in the classified areas to minimize potential for product contamination.
Must document work accurately and in a timely manner in the batch record and/or logbooks.
Must adhere to SOP’s, cGMP’s, and Safety Requirements.

Nice To Haves

Performing minor maintenance.
Performing minor maintenance of production lines.

Responsibilities

Cleaning, loading all the commodities, setup, size changeover, startup activities, and the normal operation of the batch.
May perform moderate maintenance and preventative maintenance of production lines.
Master the set-up of the filling equipment and operate and perform minor to moderate 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.
Adept at problem solving. Specifically, to identify problem, developing solution, and execute corrections while adhering to all applicable SOPs.
Required to operate advanced HMI applications.
Use of cleanroom behavior technique while in the classified areas to minimize potential for product contamination.
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 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.