<p>Description:</p> <p>The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.</p> <p>Essential Functions:</p> <ul> <li>Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for equipment /utilities/facilities and generate reports which summarize results, specification and its acceptance criteria </li><li>Performs re-qualification of equipment, facility and utilities as required </li><li>Responsible for creating validation project and validation progress reports - weekly and monthly </li><li>Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements </li><li>Provide Technical Inputs and develop strategy for various domestic and international Site Transfer projects. Provide regular status updates to the department and program management. </li><li>Closely works with the maintenance & facility teams to complete new equipment installation, commission and validation as per project requirement. </li><li>Performs engineering assessment and writes investigation reports for non-conformance </li></ul> <p>Additional Responsibilities:</p> <ul> <li>Assists with engineering projects and performs other duties as assigned. </li></ul>