Pharma Quality Validation Engineer: Critical Systems

Colgate; San José Iturbide; Presencial; MXN 240.000 - 360.000; Jornada completa

Descripción de la vacante

Colgate-Palmolive in San Jose Iturbide, Guanajuato, Mexico is seeking a Temporal Quality Validation Engineer to lead validation of critical systems, cleanrooms and equipment in a highly regulated manufacturing environment.

You will develop protocols for C&S validation, ensure compliance with FDA/Cofepris and 26 Corporate Quality Standards, and act as SME during audits.

Required: Bachelor's in Engineering and 2+ years in pharma/high-compliance manufacturing, with English proficiency.

Formación

• Bachelor's degree in Chemical Engineering, Industrial, or Mechanical Engineering.
• 2+ years of experience in pharmaceutical or high-compliance manufacturing operations.
• Deep knowledge of Cleaning & Sanitization (C&S) validation and GMP/QA practices.
• Strong regulatory familiarity with FDA and Cofepris standards for Pharma/API environments.
• Solid understanding of GMP, Process Engineering and Quality Management Systems.
• Intermediate-Advanced English proficiency.

Responsabilidades

• Lead validation of HVAC, water systems, cleanrooms and pharmaceutical equipment.
• Develop and monitor Cleaning & Sanitization validation protocols.
• Ensure compliance with FDA/Cofepris and corporate quality standards.
• Implement Validation Master Plans and change controls.
• Lead internal and external audits, providing technical evidence.
• Collaborate with Engineering, Quality and Operations teams.

Conocimientos

Process Engineering

GMP

Quality Management Systems

Educación

Bachelor's degree in Chemical Engineering, Industrial, or Mechanical Engineering

Herramientas

Validation instrumentation

Validation software

Descripción del empleo

Colgate-Palmolive in San Jose Iturbide, Guanajuato, Mexico is seeking a Temporal Quality Validation Engineer to lead validation of critical systems, cleanrooms and equipment in a highly regulated manufacturing environment.

You will develop protocols for C&S validation, ensure compliance with FDA/Cofepris and 26 Corporate Quality Standards, and act as SME during audits.

Required: Bachelor's in Engineering and 2+ years in pharma/high-compliance manufacturing, with English proficiency.