Filling Operator II

301044 Fresenius Kabi USA, LLC; North Carolina; On-site; USD 21,000 - 32,000; Full time

Benefits offered by this job

401(k) plan with company contributions

paid vacation

holiday and personal days

employee assistance program

health benefits

Job summary

Fresenius Kabi USA in North Carolina seeks FreeFlex Bag Filling Operators II to join our manufacturing team. You will clean, load commodities, set up, perform size changeovers, start up processes, conduct in-process checks, and carry out routine maintenance in a cleanroom environment under moderate supervision.

You must follow GMPs, SOPs, batch records, and protocols, and complete required training. Proficiency with advanced HMI apps and documentation practices is essential.

Qualifications

• Must complete required training and follow all SOPs, batch records, and protocols.
• Familiar with current Good Manufacturing Practices (GMP).
• Operate advanced HMI applications and document work accurately.

Responsibilities

• Cleaning, loading all the commodities, setup, size changeover, startup activities, and the normal operation of the batch.
• Perform moderate maintenance and preventative maintenance of production lines.
• Operate filling equipment and troubleshoot mechanically in a cleanroom environment (IBFM, RCO, Overwrap).
• Review batch records for accuracy and ensure adherence to Good Documentation Practice standards.
• Adhere to SOPs, cGMPs, and Safety Requirements.
• Shadow Training of Filling Operators III.

Skills

GMP compliance

HMI operation

Documentation

Troubleshooting

Cleanroom work

Tools

IBFM

Robot Cell Overwrap (RCO)

Overwrap Machine

Job description

Job Summary

The FreeFlex Bag Filling Operators II are responsible for the cleaning, loading all the commodities, setup, size changeover, startup activities, perform in-process checks, performing minor maintenance, and the normal operation of the batch. Additionally, they may be assigned tasks related to the general upkeep of the area 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 moderate supervision from the Production Supervisor. Therefore, Filling Operators II 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: $15.58 - $22.99

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.

Benefits

• 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

• medical, dental and vision coverage
• life insurance
• disability
• 401K with company contribution
• wellness program

Responsibilities

• Cleaning, loading all the commodities, setup, size changeover, startup activities, and the normal operation of the batch.
• May perform moderate maintenance and preventative maintenance of production lines.
• Master the set-up of the filling equipment and operate and perform minor to moderate 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.
• Adept at problem solving. Specifically, to identify problem, developing solution, and execute corrections while adhering to all applicable SOPs.
• Required to operate advanced HMI applications.
• Use of cleanroom behavior technique while in the classified areas to minimize potential for product contamination.
• 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 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

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 company's global headquarters is in Bad Homburg, Germany.

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.