Filling Operator I

Fresenius Kabi; North Carolina; On-site; USD 18,000 - 28,000; Full time

Job summary

Fresenius Kabi is seeking a FreeFlex Bag Filling Operator I in North Carolina to support cleaning, loading and startup activities, and run the batch with close supervision. The role involves maintaining cleanroom discipline, operating IBFM and related equipment, and documenting processes in batch records.

You will complete required training, follow cGMPs and SOPs, and participate in on-the-job skill development while contributing to quality and safety initiatives within the manufacturing area.

Qualifications

• Must complete required training and follow all SOPs, batch records and cGMP requirements.
• Willingness to work in a cleanroom environment and adhere to safety standards.

Responsibilities

• Cleaning, loading all 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 to minimize product contamination.
• Set up filling equipment and operate and troubleshoot the IBFM, RCO, and Overwrap machines.
• Review batch records for accuracy and ensure compliance with Good Documentation Practice.
• Operate advanced HMI applications and document work in batch records/logbooks.
• Adhere to SOPs, cGMPs, and safety requirements.
• Shadow training of Filling Operators II and III.
• Perform other duties as assigned by management.
• Ensure compliance with Health, Safety, Environment, Energy and Quality Management Systems.

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.

Hourly Range: $13.61 - $20.05

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.