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 proce...