Validation Engineer III

Mightyworks       |    Location:MA       |    Country:United States Of America

<p><strong>Roles and Responsibilities:</strong></p> <ul> <li>The individual will provide Quality Assurance oversight in support of a site product enabling engineering project.</li> <li>The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various validation testing documents, deviations, and change controls.</li> <li>The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing and Quality Control (QC) instruments and therefore validation and quality assurance experience in a manufacturing and / or Quality Control laboratory GMP environment is required.</li> <li>The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc.</li> <li>Upon completion of their review, the individual will also be responsible for the release of equipment back to GMP manufacturing.</li> <li>Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations.</li> <li>Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.<br /> Release equipment and / or instruments for GMP manufacturing and / or Quality Control use as part of change control.</li> <li>Can independently assess impact and re-testing requirements in the event of a deviation.</li> <li>Interactions will primarily be between Engineering/Validation personnel. Some interaction will also occur with operation and / or quality control lab personnel and, as applicable</li> <li>Proficient in reviewing executed validation documents (change controls, protocols and test plans, validation testing documents, deviations, etc.)</li> <li>Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry.</li> <li>Thorough understanding of the equipment and / or instrument validation life cycle, including change control.</li> <li>Identify and address any potential quality impact throughout the project</li> <li>Position will be office/desk based. Position is first shift with potential for second shift / weekend coverage, on occasion. No travel from the site is required.</li> </ul> <p><strong>Education and Experience:</strong></p> <ul> <li>Equipment and instrument validation experience is required</li> <li>8+ years of experience is preferred</li> <li>QC Micro and QC analytical lab instruments validation</li> <li>Manufacturing floor instrument and equipment validation</li> <li>Execution of test plans, protocol, and deviation review</li> </ul>