Senior Validation Engineer

Description

Job Summary: Coordinate and execute process, equipment, materials, and software validations to ensure compliance with quality and regulatory requirements, and supervise validation technicians. Key Highlights: 1. Responsible for coordinating and executing process and equipment validations. 2. Supervises validation technicians and develops validation protocols and reports. 3. Participates in technical design, audits, and resolves operational issues. Description and details of responsibilities 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 Experience and Requirements * Bachelor's degree in engineering. * ENGLISH ADVANCED. * 3\+ Years 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\-. Benefits * Benefits according to the Federal Labor Law (LFT) **Number of vacancies** 1 **Department** Engineering **Contract type** Permanent **Work modality** On-site **Shift** Day shift **Working hours** Full-time **Education** Professional degree **English** Speaking: Advanced, Writing: Advanced **Willingness to travel** No