Job Summary: Lead validation strategies to ensure quality, regulatory, and product safety compliance for processes, equipment, and systems. Key Highlights: 1. Leadership in process, equipment, and system validation 2. Professional development and job stability 3. Continuous training on validation topics Validation Engineer Job Objective Plan, develop, execute, and lead validation strategies to ensure that processes, equipment, systems, and methods consistently meet quality, regulatory, and product safety requirements. Main Responsibilities Develop the Validation Master Plan (VMP). Define the risk-based validation approach. Establish validation acceptance criteria and scope. Design and approve IQ, OQ, and PQ protocols. Define Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Ensure productive process capability and reproducibility. Lead validation of production equipment, critical equipment, and measurement equipment. Oversee validation of computerized systems. Ensure compliance with applicable regulatory requirements. Apply statistical tools such as process capability, DOE, and MSA. Interpret validation data and issue technical conclusions. Participate in or lead risk analyses such as FMEA. Evaluate the technical impact of changes to processes, materials, or equipment and define revalidation needs. Review and approve validation protocols and reports. Coordinate activities among Quality, Engineering, Production, and Regulatory departments. Train personnel on validation topics. Support audits, regulatory requirements, and critical findings. Requirements Engineering degree in related fields such as Industrial, Chemical, Biomedical, Biochemistry, Mechatronics, or similar. Experience in process, equipment, system, or method validation. Knowledge of IQ, OQ, and PQ protocols. Proficiency in risk analysis and tools such as FMEA. Knowledge of statistical tools: process capability, DOE, MSA. Familiarity with applicable standards and regulations, preferably ISO 13485, NOM 241:2025 SSA, and FDA. Experience in document control and traceability. Analytical ability, leadership, cross-functional collaboration, and decision-making skills. Competencies Leadership Analytical thinking Planning and organization Effective communication Teamwork Results orientation Work Schedule Monday to Friday, 07:30 to 17:00 hrs. We Offer 100% statutory benefits 5% savings fund Savings box Social benefits plan Subsidized cafeteria Job stability Opportunity for professional development. -Requirements- Minimum education: Higher education – Bachelor's degree 2 years of experience Keywords: engineers, ingeniera, ing, engineer