Medline
Ingeniero Sr. de Validaciones
Job Description
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 sol...