The Roth Machine Operator is responsible for the setup, operation, and monitoring of Roth pleating and filter media processing equipment within a controlled high-purity cleanroom environment. This role ensures strict adherence to contamination control standards, product specifications, and regulatory requirements while meeting production targets.
Roth Machine Operator - 2pm to 10:30pm
Washington, NC
Key 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)
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 (Good Manufacturing Practices) and cleanroom standards is highly desirable
- Basic mechanical aptitude and troubleshooting skills
Skills & Competencies
- Strong attention to detail with a focus on contamination control
- Ability to strictly follow SOPs work instructions, and cleanroom protocols
- High level of accountability and documentation accuracy
- Strong problem-solving and troubleshooting skills