Perform daily and periodic cleaning, decontamination, and disinfection of ISO 5, ISO 7, and ISO 8 cleanroom suites, including ceilings, walls, floors, and equipment.Adhere strictly to gowning (PPE) requirements and aseptic behaviors to prevent the introduction of particles or microbes into controlled environments.Maintain accurate, real-time records in logbooks and electronic systems according to Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).Safely remove and dispose of biohazardous and chemical waste in accordance with safety procedures and environmental regulations.Assist with the setup and operation of monitoring equipment to track air quality, pressure differentials, and surface microbial levels.Operate and maintain cleaning equipment such as autoclaves, vaporized hydrogen peroxide (VHP) systems, and specialized filtration tools.Participate in audit readiness initiatives and immediately report any facility deficiencies or deviations from Standard Operating Procedures (SOPs).
1-4 years
1-2 years of experience in a cGMP environment (biotech, pharmaceutical, or medical device manufacturing).Associate's or Bachelor's degree in a scientific or technical field.Familiarity with aseptic techniques, ISO 14644 standards, or cleanroom gowning procedures.Experience using Quality Management Systems (QMS) or electronic batch records.Ability to troubleshoot basic equipment malfunctions and identify opportunities for process improvement.
Ability to follow complex, multi-step instructions (SOPs) with 100% accuracy.Ability to stand for extended periods and lift up to 40 lbs.Strong track record of attendance and punctuality in a shift-based environment.Effective verbal and written communication skills for reporting and team coordination.High School Diploma or GED.
High School
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