Cleanroom Operations Specialist

hace 1 semana


Mexicali, Baja California, México Intuitive A tiempo completo

**Job Summary**

The Cleanroom Operations Specialist at Intuitive is the site subject matter expert for Controlled Environment Rooms (CER) regulatory standards and compliance, operational procedures, and industry best practices. This role is responsible for managing and continuously improving existing CER operating procedures and controls.

**Key Responsibilities:**

  • Review, manage, and approve changes or modifications to CERs, including the addition of new processes, equipment, or materials.
  • Manage and review environmental and product nonconformance issues.
  • Develop, promote, and implement CER operations training programs and initiatives.
  • Train, coach, and advise colleagues and new hires as needed for CER best practices, risk management, and problem solving.
  • Drive consistent practices across all CERs onsite.
  • Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance.
  • Ensure CER service suppliers are trained to relevant procedures.
  • Challenge, continuously improve, and document CER cleaning methods, frequency, and efficacy.
  • Participate in the development of new CER specifications, commissioning, and validation for new construction.
  • Subject matter expert for cleanroom operations during quality and regulatory audits.


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