Cleanroom Operator I

How You Will Make an Impact

As a Cleanroom Operator I, you will support critical manufacturing operations by operating production equipment, executing manufacturing processes, and maintaining compliance with quality, safety, and regulatory requirements. You will perform equipment operation, production documentation, and routine manufacturing activities while following established procedures and developing your technical skills.

Day in the Life

• Operate designated critical environment processing equipment, including WFI wash systems, dryers, depyrogenation equipment, sealers, and packaging equipment, in accordance with established procedures and safety requirements.
• Execute critical manufacturing processes including washing, drying, depyrogenation, sealing, packaging, product sampling, archive management, and final packaging while meeting production schedules and quality standards.
• Maintain accurate production documentation, including SOPs, Work Instruction Outlines (WOIs), labels, and critical environment records, ensuring compliance with cGMP and quality requirements.
• Perform certified area cleaning activities and maintain cleanroom standards to support safe and compliant manufacturing operations.
• Recognize and report process events, quality concerns, or safety issues to support timely resolution.
• Follow SOPs, WOIs, JSAs, Plant Safety Rules, and cleanroom procedures while maintaining compliance with quality and safety requirements.
• Support operational excellence by following established production standards, understanding operational KPIs, and participating in 7-S workplace organization activities.
• Work collaboratively with team members, accept constructive feedback, demonstrate flexibility to support production schedules, and perform other duties as assigned.

Education & Experience

High school diploma or equivalent. No previous work experience required.

Preferred Experience

Previous experience in a cGMP manufacturing, production, operations, warehouse, or regulated manufacturing environment.

Knowledge, Skills, Abilities

• Basic knowledge of critical environment manufacturing processes and the ability to safely operate designated production equipment while following established procedures.
• Ability to execute packaging, sampling, archive management, and production documentation while meeting quality and production standards.
• Ability to read, comprehend, and follow SOPs, WOIs, JSAs, Plant Safety Rules, and other manufacturing documentation.
• Basic understanding of operational KPIs, event recognition, 7-S principles, and safe manufacturing practices.
• Effective time management and organizational skills with the ability to meet production standards and adapt to changing priorities.
• Strong communication and teamwork skills with the ability to collaborate effectively, accept constructive feedback, and demonstrate a willingness to learn and develop new skills.

Physical Requirements and Work Environment

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards.
• This is a fully on-site role.
• Ability to work in a fast-paced environment with additional overtime as required.
• This role is based in the cleanroom, which is a temperature-controlled environment.
• Cleanrooms do not allow hair products, jewelry, makeup, nail polish, acrylic nails, perfume/cologne, piercings, lip balm, lotion, chewing gum, etc.
• Some degree of Personal Protective Equipment is required including safety-toed boots (ASTM F2413-24), high visibility gear, safety glasses, cleanroom suit, hair/beard coverings, gloves, lab coat, ear plugs, etc.
• Ability to safely perform the physical requirements of the role, including standing, walking, reaching, bending, twisting, stooping, pushing, pulling, forceful gripping, repetitive hand movements, and lifting up to 50 pounds unassisted.
• Loud noises (Equipment/Machinery).