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Validation Engineer III

hace 2 meses


Ciudad de México, Ciudad de México BEPC Incorporated A tiempo completo

Job Summary: BEPC Incorporated is seeking a highly skilled Validation Engineer III to join our team of consultants in the Ciudad Juarez area. This role is responsible for working on the shop floor to define the impact of variant parts and components, directly collaborating with associates, group leaders, and supervisors.

Key Responsibilities:

  • Provide technical engineering support for validations, write and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.
  • Provide technical engineering support for validations, write and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.
  • Provide technical engineering support for validations, write and execute Computer Systems Validation (CSV) protocols.
  • Provide technical engineering support for validations, write and execute Total Maintenance Validation (TMV) protocols.
  • Run experiments during the pre-validation phase and other experiments as needed.
  • Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).
  • Demonstrate sufficient knowledge in validation skills, GMP, and Good Documentation Practices (GDP).
  • Execute validation, including the creation of forms to create calibration and preventive maintenance records.

Requirements:

  • Engineering Degree (Master's in Science is a plus)
  • 3-5 years of experience in the manufacturing industry and/or 3-4 years of experience in the medical industry
  • Good presentation skills before groups/clients
  • Intermediate knowledge in statistics
  • Intermediate knowledge of Six Sigma, DMAIC, and Kaizen
  • Intermediate English level (reading and writing) with intermediate conversation skills