Aseptic Filling Operator I

301044 Fresenius Kabi USA, LLC; North Carolina; On-site; USD 19,000 - 28,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation and holidays

Health, dental, and vision coverage

Life Insurance

Wellness program

Job summary

Fresenius Kabi USA is seeking a technician to operate and monitor a state‑of‑the‑art aseptic filling line. The role requires strict adherence to SOPs, cGMPs and cleanroom procedures to minimize contamination risk.

Responsibilities include loading materials, startup activities, daily operation, and supporting basic maintenance. Accurate batch‑record documentation and compliance with safety requirements are essential as you contribute to high‑quality injectable products.

Qualifications

• Operate aseptic filling equipment following SOPs and cGMP.
• Maintain cleanroom procedures to prevent contamination.
• Follow SOPs and safety requirements; keep accurate records.

Responsibilities

• Cleaning, loading materials, startup activities, and normal operation of the batch.
• May perform minor preventive maintenance of production lines.
• Use cleanroom behavior to minimize contamination in classified areas.
• Review batch records for accuracy and compliance with GxP standards.
• Operate advanced HMI applications and document work timely.
• Adhere to SOPs, cGMPs, and safety requirements.
• Shadow training of Filling Operators II and III.
• Perform other duties as assigned by management.
• Ensure compliance to Health, Safety, Environment, and Quality Management Systems.

Skills

Aseptic technique

Cleanroom behavior

cGMP compliance

HMI operation

Documentation accuracy

Safety awareness

Tools

HMI software

Job description

Job Summary

Responsible for operating and monitoring a state of the art, aseptic filling machine in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic technique to minimize potential for product contamination.

Responsibilities PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• 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.
• 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

Hourly Range

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.

Benefits offered

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage
• medical, dental and vision coverage
• life insurance
• disability
• 401K with company contribution
• wellness program

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. Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr