Quality Validation Engineer (Temporal)

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

Quality Validation Engineer (Temporal)

Empresa : Colgate Tipo de empleo : Tiempo completo San José, Mexico

No Relocation Assistance Offered

Job Number#173414 - San Jose Iturbide, Guanajuato, Mexico

Colgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!

Join Colgate-Palmolive, a caring, innovative growth company reimagining a healthier future for people, their pets, and our planet. Guided by our core values—Caring, Inclusive, and Courageous—we foster a culture that inspires our people to achieve common goals. Together, let's build a brighter, healthier future for all.

Role Summary

The Process and Systems Validation Coordinator is a high-level technical role responsible for ensuring that all manufacturing processes, systems, and equipment—particularly within cleanroom and pharmaceutical environments—comply with the highest quality and safety standards. This role leads the implementation of Validation Master Plans (VMP) to guarantee system consistency and accuracy. By aligning plant operations with the26 Corporate Quality Standards,FDA, andCofeprisregulations, this position is critical in maintaining product purity and ensuring full regulatory readiness.

Key Responsibilities

• Critical Systems Validation:Lead and execute validation activities for critical systems (HVAC, Water for Injection/Purified Water), cleanroom areas, and specialized pharmaceutical equipment to ensure full compliance.

• Specialized Protocols:Develop and monitor specific protocols for Cleaning & Sanitization (C&S) validation, ensuring that all procedures effectively eliminate cross-contamination risks.

• Regulatory & Corporate Compliance:Ensure strict adherence to the 26 Corporate Quality Standards and NOM/FDA/Cofepris regulations through the precise interpretation and implementation of validation requirements.

• Validation Master Planning:Implement procedures and VMPs that define the methodology, activities, and timelines required to maintain the validated status of the entire plant.

• Change Control & Deviation Management:Manage validation-related change controls and provide rigorous follow-up on deviations, ensuring all technical functions remain accurate and safe for the intended use.

• Audit Leadership:Act as a subject matter expert (SME) during internal and external corporate audits, providing technical evidence and defending validation strategies to regulatory bodies.

Required Qualifications

• Education:Bachelor’s degree in Chemical Engineering (preferred), Industrial, or Mechanical Engineering.

• Experience:2+ years of experience in pharmaceutical or high-compliance manufacturing operations, with a proven track record in validating cleanrooms, critical systems and equipment.

• Specialized Knowledge:Deep understanding of Cleaning & Sanitization (C&S) validation and the management of pharmaceutical clean areas.

• Regulatory Expertise:Deep knowledge of FDA and Cofepris standards (specifically for Pharma/API environments).

• Technical Mastery:Solid understanding of Process Engineering, Good Manufacturing Practices (GMP), and Quality Management Systems.

• Languages:Intermediate-Advanced English proficiency.

Desired Qualifications

• Instrumentation & Software:Hands-on experience with validation instrumentation and specialized validation/statistical software.

• Project Management:Ability to coordinate multiple complex validation projects and manage contractor personnel simultaneously with high attention to detail.

Our Commitment to Inclusion

Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging. We are dedicated to ensuring that each individual can be their authentic self, is treated with respect, and is empowered by leadership to contribute meaningfully to our business.

Equal Opportunity Employer

Colgate is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, ethnicity, age, disability, marital status, veteran status (United States positions), or any other characteristic protected by law.

Reasonable accommodation during the application process is available for persons with disabilities. Please complete this request form should you require accommodation.