Validation Engineer II

hace 23 horas

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
Validation Engineer II (Quality)
to join our fast-growing team of consultants

KEY RESPONSABILITIES:

  • Provide technical engineering support for validation activities in regulated medical device manufacturing environments, including compliance with FDA, ISO 13485, and GMP requirements.
  • Write and execute Installation Qualification (IQ) protocols and collect, analyze, and document data to support validation completion reports.
  • Write and execute Operational Qualification (OQ) protocols, ensuring validation evidence meets quality and regulatory standards applicable to the medical industry.
  • Support the execution of experiments during the pre-validation phase, following risk-based approaches and quality guidelines.
  • Ensure assigned validation activities are performed in a timely manner and in accordance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and internal quality procedures.
  • Demonstrate working knowledge of validation principles, quality systems, deviation management, and change control within medical manufacturing processes.
  • Participate in quality-related activities such as CAPA support, non-conformance investigations, and continuous improvement initiatives.
  • Responsible for the execution of validation activities, including the creation and maintenance of calibration and preventive maintenance records in compliance with quality system requirements.

QUALIFICATIONS:

  • Engineering Degree
  • 2 – 4 years of experience in medical industry
  • Familiarity with Quality Management Systems (QMS) and regulatory standards such as ISO 13485, FDA regulations, and GMP.
  • Good presentation skills before groups/clients.
  • Intermediate knowledge in statistics.
  • Basic knowledge of Six Sigma, DMAIC and Kaizen.
  • Upper-intermediate English level

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