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This role is responsible for maintaining the cleanliness, organization, and inventory of controlled cleanroom areas to ensure compliance with Fagron Sterile Services GMP standards and internal SOPs. This role is critical to supporting sterile production operations, audit readiness, and the overall quality of our aseptic manufacturing environment.
Job Responsibility:
Perform Daily, Weekly, and Monthly sanitation tasks per schedule in controlled cleanroom environments and communicate effectively via Microsoft Teams to ensure full cleaning coverage across all areas
Assist with remediation cleanings as required
Safely handle, prepare, and apply various disinfectants in compliance with SOPs and safety data sheet (SDS) requirements
Efficiently maintaining gowning supplies (gowns, gloves, shoe covers, hair covers, face masks, etc,), ensuring they are readily available for use while following FIFO (first in, first out) method
Perform area monitoring to ensure all cleanrooms remain free of debris
remove trash and waste promptly
Accurately document all sanitation activities in a timely, GDP- and cGMP-compliant manner
Successfully complete garbing qualifications and maintain certification biannually
Ability to work within controlled environments and always maintaining aseptic techniques
Disinfect all cleanroom surfaces (e.g., counters, shelves, CWFs) by established cleaning methodologies
Maintain inventory of sanitation supplies (disinfectants, mop heads, sterile water, etc.) following FIFO (First In, First Out)
Inspect supplies for expiration or damage and dispose of items per SOPs
Stay informed of new sanitation SOPs and practices to continuously improve quality and efficiency
Assist in pre-shutdown preparations and support bi-annual Shutdown cleaning
Stay current on all training assignments and SOP revisions, including required garbing requalification
Adhere to all current SOPs and updates to maintain a continuous state of audit readiness
Maintain consistent communication with the Supervisor to provide updates, feedback, and recommendations
Report equipment repair needs, preventive maintenance requirements, and facility issues to the Supervisor and Facility Maintenance Engineer promptly
Perform other related duties as assigned
Requirements:
Prior experience in cleanroom, pharmaceutical, or GMP-regulated environment (preferred)
Prior experience safely handling and using different disinfectants
Written Communication Skills
Ability to stand for extended periods and perform repetitive cleaning tasks
Problem Solving
Oral Communication Skills (English)
Ability to lift up to 50 pounds
anything over 50 pounds will require a team lift
Strong attention to detail and ability to follow strict SOPs and documentation practices
High School Diploma or Equivalent
What we offer:
competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry