Entreprise:
Description de l'annonce:
Validation Engineer is responsible for planning, developing, implementing, and monitoring company's validation master plan
Validation engineer is responsible for ensuring process and products meet company’s requirements; running tests; analyzing and documenting resultsResponsibilities:
-Lead validations (manufacturing processes, equipment) and qualifications -Lead Validation of new products transfer -Design testing protocols that produce analyzable data -Establish performance and quality criteria -Create and run quality tests based on appropriate protocols -Evaluate manufacturing systems processes and equipment -Present validation test results and recommend improvements -Train staff on validation parameters, oversee validation team, and document processes -Coordinate validation implementation with all concerned Department, and lead validation meetings -Analyze test data to determine the causes of defects, failure, or flaws and facilitate corrective measures -Perform risk assessments and ensure compliance with applicable standards -Oversee changes and collaborate with operational team on projects -Prepare and maintain testing equipment -Keep and update activity logs -Perform troubleshooting -Measure production processes and parameters against applicable standards -Participate in operating the Quality Management System (QMS), writing procedures and processes to support the QMS development -Participate in audits -Perform internal audits -Ensure compliance with safety and quality standards Qualification required -Previous experience as a validation engineer or in a similar role -Strong understanding of manufacturing processes and safety regulations -Knowledge of statistical software analysis (e.g. MATLAB) -Bachelor's degree in engineering or a related field of specialization -Experience in equipment calibration, performance testing, and quality control. -Experience in data analysis tools and project management -Analytical and problem-solving abilities. -Leadership, collaboration, and communication skills. -Organizational and time management abilities. -Ability to ensure compliance with industry regulations. -Fluent in English |