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Maintenance Technician/GMP Cleaning Lead

Boston, MA

Akouos is building a leading gene therapy company focused on hearing disorders. We are a precision genetic medicine company focused on developing gene therapies with the potential to restore, improve and preserve high-acuity physiologic hearing for people worldwide who live with disabling hearing loss. 

Restoring, improving and preserving high-acuity hearing is an area of high unmet need in medicine: 466 million people worldwide have disabling hearing loss, and there are no FDA-approved therapies to address its underlying causes. 

Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.  Listening is in our DNA. We believe the only way to achieve our ambitious goals is to engage as one team, listen to each other, and trust in ourselves and our science. 

Job Summary:  

The Cleaning Technician is responsible for overseeing the required cleaning and sanitization tasks for the cleanrooms and facilities space at Akouos. This role reports to the GMP Facilities team and will support GMP compliance for the internal manufacturing of Akouos gene therapy products in a cleanroom environment by maintaining cleanliness standards for both viable and non-viable particulates and surfaces in the controlled manufacturing and support areas and ancillary support areas. 

Job Requirements:  

  • Follow proper methods and use prescribed materials for cleaning and sanitizing the cleanrooms and GMP support space 

  • Participate in cycle counting and inventory of cleaning supplies to maintain inventory levels and timely reordering of supplies 

  • Perform assigned tasks as scheduled while following training and Standard Operating Procedures for cleanings 

  • Work in collaboration with the GMP Facilities team to be compliant with GMP cleaning and cleanroom operational requirements 

  • Verifying that the proper sanitization agent rotation is followed and that the proper sanitization agent is used for each cleaning assignment 

  • Complete required documentation to ensure that cleaning records are maintained documenting that cleaning is properly performed and on schedule 

  • Perform daily, weekly and monthly cleaning assignments, as prescribed in the cleanroom cleaning SOPs 

  • Work effectively with cross-functional teams to develop therapies with the potential to restore, improve, and preserve hearing. 

Job Qualifications: 

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required. 

  • 1-2 years in a GMP/GLP environment including equipment and facilities cleaning 

  • Be able to witness and verify cleaning performed either by external contractors or internal teams 

  • Ability to work early starts daily and a limited amount of weekend work 

  • Working in an ISO 7 cleanroom environment and ISO 5 Biosafety cabinets and procedures for biological cleaning. Cleaning of incubators, equipment and cleanrooms 

  • Familiar with Aseptic Cleaning methods 

  • Familiar with Standard Operating Procedures and provide continuous improvement to refine SOPs 

  • All activities inside cleanroom areas will require full cleanroom gowning per SOPs including scrubs, lab coats or cleanroom suits, bouffant caps, facemask, gloves, goggles/safety glasses 

  • Ability to learn and grow in additional areas of equipment maintenance, calibration, operation and provide support with bottle gases exchange of cylinders 

  • Working in ancillary support space adjacent to the ISO areas described above to ensure cleanliness 

  • Mechanical rooms, facilities support areas and laboratory areas for general cleaning 

  • Familiar with biohazard waste and biohazard waste handling procedures 

  • Preferred experience in cleaning cleanrooms and support facilities with demonstrated proficiency in the use of sanitizing agents to thoroughly clean and disinfect surfaces and equipment to meet or exceed GMP standards 

  • Good communication skills and interpersonal skills with proven ability to speak, read and write English 

  • Attention to detail is required, must follow written work instructions, detailed documentation and record keeping 

  • Must be able to safely lift to 40 pounds 

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