Aseptic Filling Operator I

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

Benefits offered by this job

401(k) plan with company contributions

paid vacation

holiday and personal days

employee assistance program

health benefits (medical, prescription

drug, dental and vision coverage

Job summary

Fresenius Kabi USA in Wilson, NC is seeking an operator to run and monitor an aseptic filling line under cGMP guidelines. You will ensure proper aseptic technique, follow SOPs, and document batch records with accuracy.

The role includes startup activities, basic maintenance, and training of fellow operators, while maintaining a safe, compliant work environment and adherence to quality programs.

Qualifications

• Knowledge of aseptic techniques to minimize contamination.
• Ability to follow SOPs and cGMPs in a cleanroom environment.
• Accurate batch record documentation and logging.
• Comfort with operating HMI applications and manual startup tasks.

Responsibilities

• Clean, load, start up, and operate the batch on the aseptic filling line.
• Perform minor preventative maintenance on production lines.
• Maintain cleanroom behaviors to prevent product contamination.
• Review batch records for accuracy and compliance with GxP standards.
• Document work promptly and correctly in batch records/logbooks.
• Assist with shadow training of Filling Operators I/II/III.
• Adhere to safety requirements and company SOPs.
• Contribute to health, safety, environment, and quality programs.

Skills

Aseptic technique

Good documentation practices

SOP adherence

HMI operation

Cleanroom behavior

Production line maintenance support

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 SOPs, cGMPs, 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: $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 and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

• 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

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.

• medical, dental and vision coverage


• life insurance


• disability


• 401K with company contribution


• 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.