




**Job Description** **Position Summary:** Responsible for coordinating and executing the validation of processes, equipment, materials, and software, ensuring that validations comply with quality and regulatory requirements. **Main Responsibilities:** * Supervise validation technicians and provide support for production validations. * Prepare validation protocols (IQ/OQ/PQ/MVP) and reports, and coordinate all validation activities through constant communication with involved departments and personnel. * Negotiate start and completion dates for validation efforts, as well as required equipment and supplies. * Follow validation testing strategy and recommend improvements in processes and products. * 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 necessary. * Manage tasks and activities of direct subordinates and evaluate their performance. * Resolve operational problems quickly and effectively. * Coordinate and organize the development and implementation of projects. * Define strategies, resources, and phases to carry out projects. * Be responsible for complying with Medline's codes of conduct, regulations, and policies. * Other responsibilities that may be assigned according to quality procedures. **Education:** * Professional degree in Engineering or related fields. Knowledge/Skills: * 2\+ years of experience in engineering validation processes. * 1\+ year working under FDA/ISO 13485 regulated environments. * GMPs, Lean Manufacturing, 5S. * Ability to manage multiple projects. * Decision making. * Disciplined and organized. * Sense of urgency. * Assertive communication. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.


