Ingeniero Sr. de Validaciones

Descripción

Resumen del Puesto: Coordinar y ejecutar validaciones de procesos, equipos, materiales y software, asegurando el cumplimiento de requisitos de calidad y normativos, y supervisar técnicos de validación. Puntos Destacados: 1. Responsable de coordinar y ejecutar validaciones de procesos y equipos. 2. Supervisa técnicos de validación y elabora protocolos e informes de validación. 3. Participa en diseño técnico, auditorías y resuelve problemas operacionales. Descripción y detalle de las actividades Responsible for coordinating and executing process, equipment, materials and software validations, and assuring validations are in compliance with the quality and regulatory requirements. Supervise validation technicians Prepare validation protocols (IQ/OQ/PQ/MVP) and reports and coordinate all validation activities through constant communication with affected departments and personnel Negotiate start and completion dates for validation efforts, required equipment and supplies Follow validation testing strategy and recommend process and product improvements Support, organize and participate in technical design reviews, peer reviews, team meetings, and process audits Ensure closure of process validation issues. Train operational users as required Manage the tasks and activities for direct reports and evaluate their performance Quick and effective problem solving in the operation Coordinate and organize the development and implementation of projects Define strategies, resources and phases to accomplish the projects Responsible for following the codes of conduct, regulations and policies of Medline Others responsibilities that could be assigned in the procedures of the quality system Participate in the 5s program Support and participate in Kaizen events Validations production support Experiencia y requisitos * Bachelor's degree in engineering. * ENGLISH ADVANCED. * 3\+ Year in Engineering and Process Validations. * 2\+ Years working in FDA/ISO 13485 regulated environment * GMP's * Lean Manufacturing, * 5S/FDA. \-Office Windows: Excel, Power Point, Word \- Advanced\-. Beneficios * Beneficios de acuerdo a la LFT **Número de vacantes** 1 **Área** Ingeniería **Contrato** Permanente **Modalidad** Presencial **Turno** Diurno **Jornada** Tiempo Completo **Estudios** Carrera con título profesional **Inglés** Hablado: Avanzado, Escrito: Avanzado **Disponibilidad p. viajar** No