Quality Validation Engineer (Temporal) (Guanajuato)

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 the 26 Corporate Quality Standards, FDA, and Cofepris regulations, 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.