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.

Requirements:

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 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) 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 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 AAF International is an Equal Opportunity Employer M/F/Disability/Veteran. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, sex, sexual orientation, gender identity, national origin, citizenship, veteran status, uniform servicemember status, age, disability or any other legally recognized protected personal characteristics.