Ingeniero Sr. de Validaciones

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 proble...