Validation Engineer

Description

Job Summary: Lead validation strategies to ensure compliance with quality, regulatory, and product safety requirements. Key Highlights: 1. Development of the Validation Master Plan (VMP) and risk-based approach. 2. Leadership in equipment validation and oversight of computerized systems. 3. Opportunity for professional development and job stability. 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 manufacturing 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, Biochemical, 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 regulations and standards, 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 Working Hours Monday to Friday, 07:30–17:00 hrs. We Offer 100% statutory benefits 5% savings fund contribution 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