Pharma Validation Engineer - Cleanroom & Compliance Lead

Colgate; San José Iturbide; Presencial; MXN 420.000 - 600.000; Jornada completa

Descripción de la vacante

Colgate invites applications for a Quality Validation Engineer (Temporal) in Mexico. The role focuses on validating manufacturing processes, systems, and equipment, especially in cleanroom and pharmaceutical environments, to meet high quality and regulatory standards.

You will lead Validation Master Plans, ensure compliance with FDA and Cofepris, and support audits with technical evidence. English proficiency is required.

Formación

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

Responsabilidades

• Lead and execute validation activities for critical systems (HVAC, Water for Injection/Purified Water), cleanroom areas, and specialized pharmaceutical equipment.
• Develop and monitor validation protocols for Cleaning & Sanitization (C&S) validation to prevent cross-contamination.
• Ensure compliance with 26 Corporate Quality Standards and FDA/Cofepris regulations through precise validation requirements.
• Implement Validation Master Plans (VMPs) defining methodology, activities, and timelines.
• Manage validation-related change controls and follow-up on deviations for safety and accuracy.
• Act as SME during internal and external audits, providing technical evidence to regulators.

Conocimientos

GMP knowledge

Process engineering

Quality management systems

FDA and Cofepris regulatory knowledge

English proficiency

Educación

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

Descripción del empleo

Colgate invites applications for a Quality Validation Engineer (Temporal) in Mexico. The role focuses on validating manufacturing processes, systems, and equipment, especially in cleanroom and pharmaceutical environments, to meet high quality and regulatory standards.

You will lead Validation Master Plans, ensure compliance with FDA and Cofepris, and support audits with technical evidence. English proficiency is required.