<p>AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.</p> <p>Job Description</p> <p>AbbVie Bioresearch Center in Worcester, MA is seeking an Engineer with significant experience in the validation of biologics equipment to join the Validation Engineering Group.</p> <p>The selected candidate will be responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment. The engineer will work in a multi-disciplinary team environment.</p> <p>Primary Responsibilities:</p> <ul> <li>Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required </li><li>Execute assigned projects, jobs and tasks according to schedule prepared by Engineering Project Management </li><li>Provide input on risk assessments and system classifications </li><li>Review new equipment specifications </li><li>Manage continuous improvement projects and drive to completion </li><li>Mentor and guide junior engineers and validation associates in the development and execution of equipment change control plans and qualification/validation test protocols </li><li>Work with appropriate departments and personnel to resolve validation testing issues </li><li>Advise other departments on SOPs related to validation projects </li><li>Maintain 100% on time training </li><li>Achieve Site, Department and Group performance metrics </li><li>Complete other special projects and assignments as required </li><li>Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs </li></ul> <p>Qualifications</p> <p>Qualifications</p> <p>Education:</p> <ul> <li>BS Degree in engineering or technical discipline with a minimum of minimum of 5+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes. </li></ul> <p>Background:</p> <ul> <li>An understanding of basic unit operations involving cell culture and protein purification is required </li><li>Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is required </li><li>Familiarity with Clean-In-Place and Steam-In-Place theory and techniques is required </li><li>Experience with risk-based approach to commissioning and qualification preferred </li><li>Experience with temperature mapping of environmental chambers, autoclave validation is desired </li><li>Familiarity with distributed control systems and process logic controllers is required </li><li>Must have familiarity with P&IDs, loop diagrams, etc. </li><li>Must have hands-on experience on the Kaye Validator </li><li>Familiarity with project management is preferred </li><li>Experience with continuous improvement to streamline practices & procedures is preferred </li><li>Adherence to cGMP and GDP is required </li><li>Strong technical writing skill is required </li><li>Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred </li><li>Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously </li><li>Must demonstrate strong interpersonal & teamwork skills </li></ul> <p>Additional Information</p> <p>Applicable only to applicants</p>