REVIANAbout RevianREVIAN Inc, an operating subsidiary of KNOW Bio, LLC, is a medical technology innovator dedicated to stimulating the body's natural processes to rejuvenate hair and skin with light.
We create products that precisely deliver light and allow people to experience its regenerative potential in the convenience of their own home.
We are searching for a self-motivated Senior Validation Engineer (Contract, Full Time) to join our Quality team. The primary focus of this position will be to validate computer systems software and systems. The candidate must have experience in all phases and deliverables of validation including, but not limited to, development of requirements including process maps, risk analyses, plans, test protocols, and test reports to develop a validation master file.
Extensive software validation is a must. The work will be performed on site in Morrisville, NC. The incumbent engineer will play a pivotal role in ensuring the Quality Management System meets US FDA and ISO 13485 requirements with respect to equipment and computer systems validation.
Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or assume responsibility for on-going sponsorship of an employment Visa at this time.
Senior Validation Engineer (Contract, Onsite Required)
Principal Duties & Responsibilities:
Develop and execute computer software systems validations for off the shelf and custom designed software and spreadsheets in accordance with FDA guidance documents, specifically, Computer Software Assurance for Production and Quality Management System Software (Feb 3, 2026) and General Principles of Software Validation, as well as ISO 13485 computer system validation requirements.
Develop and execute equipment and process validations for internal company equipment/processes including custom designed equipment allocated and transferred to contract manufacturers.
Develop a master validation file for equipment/software including but not limited to validation plans, requirements, risk analyses, test protocols, and test reports.
Assist Quality in Change Management.
Perform duties and other analyses as requested by members of management.
Adhere to and ensure compliance with Revian's quality system.
Required Skills & Qualifications:
BSc, MSc, or PhD in an engineering or physical science field.5+ years of experience in the medical device industry and within a Quality System compliant with 21 CFR 820 or ISO 13485.
5+ years of experience in Computer System Validation for the Medical Device industry.
Ability to work with teams on site to develop and document requirements. Excellent written skills a must have.
Prioritize and manage multiple projects in a fast-paced environment with minimal supervision while maintaining strong attention to detail.
Self-starting and self-motivating team player with the ability to work autonomously.
Willingness to quickly adapt to changing priorities and manage multiple tasks.
Strong interpersonal skills, effective written and verbal communication, problem solving, and decision-making skills.
Experience with measurement methods and measurement equipment.
Detailed knowledge of Microsoft Project, Smartsheet, or other project management software.
Physical Demands and Work EnvironmentThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the principal duties and responsibilities.
Typical office environment requirements include reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing), and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours, consistent with other Manager-level positions. Some travel may be required (5-10%).
KNOW Bio maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
KNOW Bio is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.
Full-time
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