Senior Validation Engineer

hace 6 días

Juárez, Chihuahua, México BEPC Inc. - Business Excellence Professional Consulting A tiempo completo

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

BEPC has a Ciudad Juarez area OPEN POSITION for
Senior Validation Engineer
to join our fast-growing team of consultants

KEY RESPONSABILITIES:

  • 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 Performance Qualification (PQ) 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.
  • Provide technical engineering support for validations, write, and execute SAT (Factory Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.
  • Responsible for running experiments during the pre-validation phase, run 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, Good Documentation Practices (GDP).
  • Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.

QUALIFICATIONS:

  • Engineering Degree (master's in science is a plus)
  • 4 - 6 years of experience in the manufacturing industry and/or 5 – 6 years of experience in medical industry
  • Good presentation skills before groups/clients.
  • Solid skills in developing Factorial Experiments (DOE).
  • Extensive knowledge in Lean.
  • Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
  • Intermediate knowledge in Project Management.
  • Extensive knowledge in statistics.
  • Advanced English level (reading and writing) with intermediate conversation skills.

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