Filling Operator I

Fresenius•Wilson, NC

4d•Onsite

About The Position

This role involves operating and maintaining filling equipment in a cleanroom environment. The Filling Operator I is responsible for cleaning, loading commodities, performing startup activities, and operating the batch process. They will also perform minor maintenance and preventative maintenance on production lines. A key aspect of this role is adhering to cleanroom behavior techniques to prevent product contamination. The operator will learn to master the setup, operation, and minor troubleshooting of Integrated Bag Making Filling Machines (IBFM), Robot Cell Overwrap equipment (RCO), and Overwrap Machines. Accurate and timely documentation in batch records and logbooks is crucial, following Good Documentation Practice standards. The role requires operating advanced HMI applications and ensuring compliance with SOPs, cGMPs, and safety requirements. Additionally, the Filling Operator I will train Filling Operators II and III through "shadow" training and perform other duties as assigned. They are responsible for compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems.

Requirements

Experience with cleanroom behavior technique.
Ability to operate advanced HMI applications.
Proficiency in documenting work accurately and in a timely manner in batch records and/or logbooks.
Adherence to SOP’s, cGMP’s, and Safety Requirements.
Understanding of Good Documentation Practice standards.

Nice To Haves

Experience with Integrated Bag Making Filling Machines (IBFM).
Experience with Robot Cell Overwrap equipment (RCO).
Experience with Overwrap Machines.
Experience performing minor mechanical troubleshooting.
Experience performing minor maintenance and preventative maintenance.

Responsibilities

Cleaning, loading all the commodities, startup activities, and the normal operation of the batch.
Performing minor maintenance and preventative maintenance of production lines.
Using cleanroom behavior techniques while in 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.
Performing peer to peer batch record documentation review throughout the shift to ensure documentation is accurate and in alignment to the Good Documentation Practice standards.
Operating advanced HMI applications.
Documenting work accurately and in a timely manner in the batch record and/or logbooks.
Adhering to SOP’s, cGMP’s, and Safety Requirements.
Performing “shadow” training of Filling Operators II and III.
Performing other duties as assigned by management.
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.