Filling Operator I

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

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.

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.
• Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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, and wellness 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.