Engineering Intern Quality Engineering

Description The Quality Engineering Intern will work with multi-disciplinary teams within Vivex Biologics, Inc. and assist Quality Engineers with continuous improvement projects to ensure our products continue to meet all regulatory and internal quality standards. Projects include but are not limited to quality investigations, validation activities, risk management, data analysis, and development of new tools for process efficiencies and compliance. Requirements Duties and responsibilities Assist with quality investigations to resolve deviations (NC, CAPA, Planned Deviations, etc.). Performing data analysis for metrics trending, and process characterization. Support validation activities (e.g. equipment qualification, process validation, test method validation). Execute process characterization activities. Participate in the creation of process risk assessments (pFMEA). Participate in project planning. Develop design of experiments and execute accordingly under supervision as assigned. Deliver protocols, reports, and presentation as required. Other duties as assigned. Qualifications Pursuing bachelor's or master's degree in engineering, life sciences/health related field. Minimum GPA 3.0. Demonstrates ba s ic knowledge in human anatomy, biology, physics, statistics, and chemistry. Strong verbal and written communication skills (technical writing), analytical and problem-solving skills, troubleshooting and organizational skills, including project planning. Proficient in Microsoft Office (Excel, Word, PowerPoint). Knowledge in Microsoft Visio, Microsoft Project preferred. Power BI knowledge a plus. Prior internship experience in a regulated industry, a plus. Working conditions The job may require work inside the controlled cleanroom manufacturing area where the intern would be exposed to tissue processing. Physical requirements The job may entail the occasional requirement to stand for extended periods of time and lift heavy objects of up to 30 lbs. Direct reports No direct reports. Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Vivex Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training. Vivex Biologics complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.