Filling Operator I

Fresenius Kabi•Wilson, NC

20h

About The Position

FreeFlex Bag Filling Operators I clean and load commodities, perform startup activities and in-process checks, and operate production batches. They may also help maintain the area, perform size changeovers, set up production lines, and conduct minor maintenance. The work is governed by strict procedures and regulations and requires substantial training and close supervision by the Production Supervisor. Operators must complete required training and follow applicable Standard Operating Procedures, Batch Records, and Protocols, while maintaining familiarity with current Good Manufacturing Practices. The role involves learning to set up and operate filling and overwrap equipment in a cleanroom environment, using cleanroom practices to minimize product contamination. Operators document work accurately and promptly, review batch-record documentation with peers, operate advanced HMI applications, and comply with company safety and management-system requirements. The position may include shadow training for Filling Operators II and III. Employment is at-will and does not guarantee permanent employment.

Requirements

Complete all required training.
Follow applicable Standard Operating Procedures, Batch Records, and Protocols.
Be familiar with current Good Manufacturing Practices.
Use cleanroom behavior techniques in classified areas.
Accurately and promptly document work in batch records and/or logbooks.
Comply with safety requirements and applicable company management-system documents and programs.

Responsibilities

Clean, load commodities, perform startup activities and in-process checks, and operate production batches.
Perform minor maintenance and preventative maintenance on production lines.
Use cleanroom behavior techniques in classified areas to minimize potential product contamination.
Learn to set up filling equipment and operate and perform minor mechanical troubleshooting of the Integrated Bag Making Filling Machine (IBFM), Robot Cell Overwrap equipment (RCO), and Overwrap Machine.
Perform peer-to-peer batch-record documentation reviews during the shift to ensure accuracy and alignment with Good Documentation Practice standards.
Operate advanced HMI applications.
Document work accurately and promptly in batch records and/or logbooks.
Adhere to SOPs, cGMPs, and safety requirements.
Perform shadow training of Filling Operators II and III.
Ensure compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, according to assigned roles and responsibilities.
Perform other duties as assigned by management.
May perform general area upkeep, size changeovers, and production-line setup.