The Validation Engineering Intern will work with multi-discipline teams within Vivex Biologics, Inc. and assist the Validation Engineering Manager or designee with process and equipment validation activities, test method validation, and supporting quality systems documentation and regulatory compliance efforts. 

Duties and responsibilities

1. Assist with the development, execution, and review of validation protocols (IQ, OQ, PQ) for equipment, processes, and test methods.

2. Assist in the review of calibration certificates to ensure compliance with internal requirements.

3. Support data collection, trending, and statistical analysis for validation studies and ongoing process monitoring.

4. Participate in project planning and compilation of validation summary reports and risk assessments.

5. Develop test protocols and execute validation testing under supervision in accordance with applicable SOPs and regulatory requirements.

6. Deliver validation protocols, reports, and presentations as required.

7. Other duties as assigned.

Qualifications

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

• Bachelor’s degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Senior student in Engineering may also be acceptable. Minimum GPA 3.0.
• Demonstrates basic knowledge in quality systems, statistics, and regulatory standards (e.g., FDA 21 CFR, AATB, ISO 13485) applicable to medical device or biologics manufacturing. 
• Strong verbal and written communication skills, project planning, analytical and problem-solving skills, technical  writing, troubleshooting and organizational skills.
• Proficient in Microsoft Office (Excel, Word,PowerPoint). Knowledge in Microsoft Visio, Microsoft Project preferred. Project management skills      preferred. 

Working conditions

Job requires working in office. Must be willing to work weekends and evening hours, as necessary. Must be willing to accommodate travel, if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing and validation testing activities.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 30 pounds. 

Direct reports

No direct reports (Individual contributor role).

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. 

Vivex Biologics, Inc. 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, Inc. 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.