Precision Pleating Machine Operator (Cleanroom)

FLANDERS Inc.; Washington (NC); On-site; USD 42,000 - 64,000; 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. You will ensure contamination control, meet product specifications, and comply with GMP/ISO requirements while achieving production targets.

The role requires 1–3 years in manufacturing, experience with pleating or automated equipment, and strong attention to detail for precise adjustments and documentation.

Qualifications

• High school diploma or GED preferred.
• 1-3 years of experience in manufacturing, 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 all 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 (Good Documentation Practices).
• Perform routine cleaning and minor maintenance of equipment in compliance with cleanroom standards.
• Troubleshoot minor machine issues and elevate deviations per established procedures.
• Follow all GMP, ISO, and company quality system requirements.
• Participate in audits, training, and continuous improvement initiatives (Lean, 5S, Kaizen).

Skills

Attention to detail

SOP compliance

Documentation accuracy

Problem solving

Communication

Teamwork

Controlled environment compliance

Education

High school diploma or GED

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. You will ensure contamination control, meet product specifications, and comply with GMP/ISO requirements while achieving production targets.

The role requires 1–3 years in manufacturing, experience with pleating or automated equipment, and strong attention to detail for precise adjustments and documentation.