Sterility Assurance

hace 6 días

Juárez, Chihuahua, México Ambu AS A tiempo completo

A Global Job Position With An Impact
We are growing and expanding our Manufacturing Site in Mexico In the job as the Sterility Assurance & Microbiology Technician he is responsible for the execution of related microbiology and sterilization processes.

Responsibilities And Essential Functions

  • Participate in the overall activities related to microbiology tasks for cleanroom validation

and environmental monitoring.

  • Follow the techniques already defined to accomplish business objectives such as quality,

cost optimization and cycle-time.

  • Perform the activities related to sterilization and/or microbiology according to the Ambu

procedures.

  • Participate in small project teams as needed to accomplish project objectives.
  • Document quality records using Good Documentation Practices (GDP).
  • Apply appropriate techniques and methods to successfully conduct specific assignments

within negotiated deadlines after receiving the assignment.

  • Demonstrate basic knowledge of technical theories and principles related to Microbiology

and Sterilization for routine tasks.

  • Execute environmental monitoring testing such as Airborne Particles, Airborne Microbes,

Surface microbes and Hand hygiene testing as applicable.

  • Coordinate and follow up internally the shipment of the medical device samples for

Bioburden testing.

  • Participate in the evaluation of the alert and action levels for cleanroom and surrounding

areas by gathering historical data.

  • Participation in the logistics of samples to be tested, includes but not limited to bioburden

test samples and biocompatibility test samples.

  • Participation in the certification of sterilization cycles.
  • Participation as required during audits.
  • All other duties as assigned.

Authority

  • Execution of Environmental Monitoring and Product testing activities.
  • Participate as required in the documentation of NCRs related to sterilization deviations

and environmental monitoring following our existing procedures.

  • Escalate to Sterility Assurance & Microbiology Lead and/or Specialist any situation

that represents a quality risk.

Qualifications / Education

  • Technical degree (or bachelor's degree preferably) in Microbiology, Biology, Chemistry, or

related areas.

  • Experience of at least 1 year in the Medical Device Industry.

Required Skills

  • Must be able to speak, read, write, and understand English.
  • Good attention to detail and organizational skills.
  • Ability to work, interact, and communicate effectively with others.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to work independently with minimal supervision.

Work Environment
This is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration, or other workplace hazards controlled within compliance of current safety and health standards.

How To Apply
If you are interested in the position, then please apply as soon as possible through our recruitment system. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate.

This job ad will be online until December 05,2025, but once we have found the right candidate, this ad will no longer be online. For more information about the position, please feel free to contact

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