Cleanroom Pleating Machine Operator

Flanders, Inc.; Washington (NC); On-site; USD 42,000 - 54,000; Full time

Job summary

AAF International is seeking a Roth Machine Operator to set up, operate, and monitor pleating and filter media processing equipment in a controlled cleanroom environment. The role emphasizes contamination control, regulatory compliance, and meeting production targets.

Responsibilities include equipment setup, parameter monitoring, and rigorous documentation. The position requires gowning, adherence to GDP/cleanroom standards, and participation in audits and continuous improvement initiatives.

Qualifications

• High school diploma or GED (preferred).
• 1-3 years manufacturing experience, preferably in cleanroom, medical device, pharmaceutical, or high-purity filtration environments.
• Experience operating pleating, converting, or automated manufacturing equipment preferred.
• Familiarity with GMP and cleanroom standards is highly desirable.
• Basic mechanical aptitude and troubleshooting skills.

Responsibilities

• Set up and operate Roth pleating machines and associated equipment used in high-purity filter manufacturing.
• Perform tasks in accordance with cleanroom protocols, including gowning, material handling, and contamination control procedures.
• Monitor machine parameters and make precise adjustments to ensure product integrity and consistency.
• Load and handle filter media and components using approved clean handling techniques.
• Conduct in-process inspections to verify product quality, pleat integrity, and dimensional accuracy.
• Identify and segregate non-conforming materials in accordance with quality procedures.
• Complete accurate and timely documentation (batch records, device history records, logbooks) following GDP.
• Perform routine cleaning and minor maintenance of equipment in compliance with cleanroom standards.
• Troubleshoot minor machine issues and escalate deviations per established procedures.
• Follow GMP, ISO, and company quality system requirements.
• Participate in audits, training, and continuous improvement initiatives (Lean, 5S, Kaizen).

Skills

Attention to detail

Following SOPs

Documentation accuracy

Troubleshooting

Communication

Teamwork

Education

High school diploma or GED

Tools

Pleating machines

Automated manufacturing equipment

Job description

AAF International is seeking a Roth Machine Operator to set up, operate, and monitor pleating and filter media processing equipment in a controlled cleanroom environment. The role emphasizes contamination control, regulatory compliance, and meeting production targets.

Responsibilities include equipment setup, parameter monitoring, and rigorous documentation. The position requires gowning, adherence to GDP/cleanroom standards, and participation in audits and continuous improvement initiatives.