Senior Validation Engineer

hace 4 semanas


Ciudad Juárez, México BEPC Inc A tiempo completo

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.BEPC has a Ciudad Juarez area OPEN POSITION for **Senior Validation Engineer**to join our fast-growing team of consultants**KEY RESPONSABILITIES**:- Provide technical engineering support for validations, write, and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.- Provide technical engineering support for validations, write, and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.- Provide technical engineering support for validations, write, and execute Performance Qualification (PQ) protocols, and provide data to write completion reports for assigned validations.- Provide technical engineering support for validations, write, and execute Computer Systems Validation (CSV) protocols.- Provide technical engineering support for validations, write, and execute Total Maintenance Validation (TMV) protocols.- Provide technical engineering support for validations, write, and execute SAT (Factory Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.- Responsible for running experiments during the pre-validation phase, run other experiments as needed.- Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).- Demonstrate sufficient knowledge in validation skills, GMP, Good Documentation Practices (GDP).- Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.**BASIC QUALIFICATIONS**:- Engineering Degree (master’s in science is a plus)- 4 - 6 years of experience in the manufacturing industry and/or 5 - 6 years of experience in medical industry- Good presentation skills before groups/clients.- Solid skills in developing Factorial Experiments (DOE).- Extensive knowledge in Lean.- Intermediate knowledge in Six Sigma, DMAIC and Kaizen.- Intermediate knowledge in Project Management.- Extensive knowledge in statistics.- Advanced English level (reading, writing and conversational).MXOPSTipo de puesto: Tiempo completoSueldo: $100.00 - $200.00 al mesBeneficios:- Seguro de gastos médicos mayores- Seguro dentalExperiência:- validando en la industria médica: 4 años (Obligatorio)Idioma:- Inglés (Obligatorio)Lugar de trabajo: Empleo presencial



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