Roth Machine Operator - 2pm to 10:30pm

Description

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.

• →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) 

• 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 

• 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 

• 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 

• 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