Validation Specialist - Glassware Washer Lab. equipment

<strong>Summary:</strong><br /> The Validation Specialist will support the validation of the new Glassware Washer in the QC Laboratory of a pharmaceutical industry in Barceloneta, PR.   This full time and full on-site project assignment will support an ongoing project.  Proven experience in Glass Washer equipment and process validation is required.<br /> <br /> System to be used: Miele Model PLW 8615.  This is a Laboratory Glassware Washer designed to cleaning, rinsing, and drying of llaboratory glassware, utensils and similar categorized components using water-based media.<br /> <br /> <strong>Responsibilities:</strong> <ol> <li>LEVA Documentation, Discrepancy and Risk Assessment:  Develop all validation deliverables not limited to the following:  Roles Assignment Log, Validation Plan, User Requirements, Risk Assessment, Configuration Specifications, Part 11 Assessment, URS, IOQ, PQ, Validation Summary Report and other) for the validation of Equipment.</li> <li>Vendor Equipment Start up and IOQ Execution:  Support during Vendor Start up and vendor IOQ Execution.</li> <li>SOP:  Generation of Operational and administration Procedures.</li> <li>PM, Calibration and Spare Parts:  Incorporate equipment in PM, CAL &amp; Spare Parts Program.</li> <li>Generate Weekly Reports:  Project Status Report</li> <li>Support Any Drawings Update:  Redlines of Drawings</li> <li>Support other tasks as assigned.</li> </ol> <br /> <strong>Requirements:</strong> <ul> <li>Bachelor´s degree in Science, Engineering or Administration</li> <li>3-5 years of direct related experience in validation of Glassware Washers or similar equipment to be used in a GxP process - Laboratory area in a pharmaceutical manufacturing environment.</li> <li>Good technical skills, able to learn the new technology and good communication and organization skills. </li> </ul> <br /> <strong>Work Methodology:</strong> <ul> <li>Full time, full on site assignment in Barceloneta, PR</li> <li>Professional services contract classification</li> <li>3 months of this first assignment</li> <li>Administrative shift and willing to work non administrative hours.</li> </ul>