Roth Machine Operator - 2pm to 10:30pm

Shift: 2pm to 10:30pm • Location: Washington, NC

About the role

Set up, operate, and monitor Roth pleating and filter media processing equipment within a controlled high-purity cleanroom environment. Ensure strict adherence to contamination control standards, product specifications, and regulatory requirements while meeting production targets.

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 escalate deviations per established procedures
• Follow all GMP, ISO, and company quality system requirements
• Participate in audits, training, and continuous improvement initiatives (Lean, 5S, Kaizen)

Requirements

• 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
• Effective communication and teamwork
• Ability to work in a highly controlled, regulated environment

Cleanroom & Physical Requirements

• Ability to work in ISO-classified cleanroom environments
• Must comply with gowning requirements (coveralls, hood, gloves, mask, booties)
• Ability to stand for extended periods (8–12 hour shifts)
• Ability to lift up to 25–40 lbs
• Ability to perform repetitive tasks with precision and consistency
• No cosmetics, jewelry, or prohibited materials as defined by cleanroom policy

Work Environment

• Controlled cleanroom manufacturing environment producing high-purity filtration products
• Strict environmental and contamination controls (HEPA filtration, airlocks, pressure differentials)
• Regular audits and inspections for compliance with quality and regulatory standards