Validation Engineer

Description

Job Summary: Execute and technically coordinate the qualification and validation of manufacturing processes, equipment cleaning, and water systems, ensuring compliance with GMP regulations. Key Highlights: 1. Experience in process validation, cleaning, and system qualification. 2. Solid knowledge of GMP and regulatory frameworks (FDA, COFEPRIS, EMA). 3. Development and execution of qualification and validation protocols and reports. **Job Objective** To execute and technically coordinate **qualification and validation activities** for manufacturing processes, equipment cleaning, and water systems, ensuring compliance with **Good Manufacturing Practice (GMP) requirements**, regulatory expectations (FDA, COFEPRIS, EMA), and the organization’s Quality Management System. Essential Requirements: * Engineering or related bachelor’s degree (Pharmaceutical, Chemical, Industrial, Biotechnology, or similar). * Experience in **process validation, cleaning, and system qualification** within regulated industries. * Solid knowledge of **GMP** and regulatory frameworks **FDA, COFEPRIS, and EMA**. * Ability to perform technical documentation and interdisciplinary collaboration. * **Technical–operational profile**, execution-oriented, organized, and possessing effective communication skills. **Key Responsibilities** * Develop and **execute qualification and validation protocols** for: * Manufacturing processes * Equipment cleaning validation * Water systems (potable water, purified water, WFI, as applicable) * Prepare **qualification and validation reports**, including data analysis, evaluation of results, deviations, and technical conclusions aligned with GMP principles. * Verify compliance with **validation prerequisites** (equipment status, calibrations, SOPs, utilities, personnel training) prior to protocol execution. * Collect, review, and safeguard **objective evidence** generated during validation activities, ensuring traceability, data integrity, and documentary compliance. * Monitor and ensure maintenance of the **validated state** of processes, equipment, and systems included in the **Master Validation Plan (MVP)**. * Coordinate and technically monitor validation activities jointly with involved departments (Production, Quality, Engineering, Maintenance). * Coordinate and provide technical supervision of **external vendors** performing qualification or validation activities, ensuring compliance with regulatory and quality requirements. * Monitor the **Calibration Program** executed by the Maintenance department, verifying that calibration status supports validation activities. * Actively participate in the **Validation Committee**, providing technical input for risk assessment and decision-making. * Collaborate in the development, review, and maintenance of the **Master Validation Plan (MVP)**. * Develop, review, and maintain up-to-date **procedures, work instructions, and templates** related to validation activities. * Maintain continuous communication with involved departments to identify validation needs, changes, and potential impacts on the validated state. Salary: $25,000\.00 \- $27,000\.00 per month Benefits: * Medical expense insurance * Life insurance * Cafeteria service * Grocery vouchers Workplace: On-site employment