Analista de Validación

About the role

We are looking for a Validation Analyst to design, execute and document qualification and validation activities for equipment, systems and processes within our pharmaceutical manufacturing facilities. The role ensures compliance with applicable regulatory standards and supports continuous improvement of our production environment.

Key responsibilities

• Plan and schedule equipment qualifications and validations according to assigned scope.
• Execute tests defined in approved qualification/validation protocols, analyse results and prepare detailed reports with conclusions for operation.
• Monitor and follow‑up any deviations identified during qualification or validation activities.
• Provide technical support to engineering and internal users for improvement projects involving facilities, equipment or processes.
• Maintain activities in line with the Quality System and Good Manufacturing Practices (GMP).

Required profile

• Bachelor’s degree in Chemical‑Pharmaceutical, Chemical‑Biological or a related field.
• Experience in pharmaceutical manufacturing, specifically in qualification and validation of areas, services, equipment or processes.
• Familiarity with regulatory requirements such as NOM‑059, FDA and Health Canada.
• Availability to work according to the required schedule.

Required skills

• Good Manufacturing Practices (GMP) knowledge – NOM‑059, FDA, Health Canada.
• Microsoft Office suite (Word, Excel, PowerPoint).
• Descriptive and inferential statistical analysis.
• Technical fundamentals of equipment operation, design and process engineering.