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 the development of new tools for process efficiencies and compliance.

• Assist with quality investigations to resolve deviations (NC, CAPA, Planned Deviations, etc.).
• Perform data analysis for metrics trending and process characterization.
• Support validation activities (e.g., equipment qualification, process validation, test method validation) and 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 presentations as required.
• Other duties as assigned.

• Pursuing a bachelor’s or master’s degree in engineering, life sciences, or a health-related field. Minimum GPA 3.0.
• Demonstrates basic knowledge in human anatomy, biology, physics, statistics, and chemistry.
• Strong verbal and written communication skills, analytical and problem‑solving skills, troubleshooting and organizational skills, including project planning.
• Proficient in Microsoft Office (Excel, Word, PowerPoint). Knowledge of Microsoft Visio and Microsoft Project preferred. Power BI knowledge a plus.
• Prior internship experience in a regulated industry is a plus.

The job may require work inside the controlled cleanroom manufacturing area where the intern would be exposed to tissue processing.

The job may entail the occasional requirement to stand for extended periods of time and lift heavy objects of up to 30 lbs.

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.

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 Disabilities Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.