Bag Filling Operator I — Cleanroom Production & Setup

Fresenius Kabi USA; Wilson (NC); On-site; USD 19,000 - 28,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical, dental, and vision coverage

Life insurance

Disability insurance

Wellness program

Job summary

Fresenius Kabi USA in Wilson, NC is seeking a FreeFlex Bag Filling Operator I to join our biotech manufacturing team. You will handle cleaning, loading commodities, startup tasks, and in-process checks to run batches under close supervision.

You will follow SOPs, batch records, and cGMPs, operate IBFM, RCO and Overwrap equipment in a cleanroom, perform minor maintenance, and contribute to safety and quality programs.

Qualifications

• Must complete required training and follow SOPs, batch records, and protocols.
• Familiar with current Good Manufacturing Practices (cGMP).
• Experience operating IBFM, RCO, and Overwrap machinery.

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

Skills

Cleanroom protocol

Documentation accuracy

HMI operation

Mechanical troubleshooting

Tools

IBFM

RCO

Overwrap Machine

HMI software

Job description

Fresenius Kabi USA in Wilson, NC is seeking a FreeFlex Bag Filling Operator I to join our biotech manufacturing team. You will handle cleaning, loading commodities, startup tasks, and in-process checks to run batches under close supervision.

You will follow SOPs, batch records, and cGMPs, operate IBFM, RCO and Overwrap equipment in a cleanroom, perform minor maintenance, and contribute to safety and quality programs.