Senior Validation Engineer
EmitBio
- Morrisville, North Carolina, United States
- Morrisville, North Carolina, United States
À propos
Revian 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.
*Opportunity*
We are seeking a self‑motivated Senior Validation Engineer for a 6‑month onsite contract to support Computer System Assurance (CSA) activities for key non‑product software systems, including ERP and other QMS‑related platforms. This role will focus on ensuring that critical business systems generate accurate data, maintain compliant electronic records, and meet applicable regulatory requirements.
The ideal candidate brings strong medical device industry experience and a practical, risk‑based approach to software validation. This is an excellent opportunity to make an immediate impact by helping streamline and strengthen our validation framework during a period of rapid operational growth.
*Work Authorization*
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.
*Position Title: *Senior Validation Engineer (Contract – Onsite Required)
*Reports To: *Quality/Engineering
*Principal Duties & Responsibilities:*
· Lead Computer System Assurance (CSA) activities for designated non‑product software systems.
· Develop, review, and execute validation deliverables, including URS, risk assessments, test plans, test protocols, and validation reports.
· Partner with system owners and cross‑functional teams to define intended use, critical functionality, and validation scope.
· Perform testing activities, document objective evidence, and manage deviations or discrepancies.
· Support system lifecycle activities including change management, impact assessments, and revalidation as required.
· Ensure validated systems maintain data integrity, compliant electronic records, and appropriate security/access controls.
· Collaborate with Quality, Customer Support, Operations, and vendors to maintain validated state throughout the system lifecycle.
· Contribute to continuous improvement of the CSA process by applying FDA CSA guidance and right‑sized validation practices.
· 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:*
· 5+ years of experience in Computer System Validation or Computer System Assurance within the medical device industry.
· Demonstrated experience validating non‑product (GxP‑relevant) software systems such as ERP, QMS, document control, training management, or inventory/traceability platforms (e.g., NetSuite or similar).
· Strong knowledge of 21 CFR Part 820, ISO 13485, and 21 CFR Part 11, with practical experience validating systems that manage regulated records.
· Proven ability to apply risk‑based validation and CSA principles to ensure compliance while avoiding excessive documentation.
· Ability to work collaboratively onsite with cross‑functional teams to define requirements and validation needs.
· Excellent written and verbal communication skills, including the ability to produce clear, audit‑ready documentation.
· Strong organizational and analytical skills with the ability to manage multiple projects simultaneously in a fast‑paced environment.
· Bachelor’s, Master’s, or PhD in Engineering or a physical science discipline.
*Desired Skills*
· Strong project management skills with the ability to plan, prioritize, and drive validation activities to completion within defined timelines.
· Experience preparing for or supporting external audits related to software systems or quality systems.
· Ability to translate regulatory and quality requirements into practical, right‑sized validation strategies.
· Experience coordinating efforts across multiple departments and external vendors.
· Self‑starter comfortable working with minimal oversight and capable of proactively identifying risks or gaps.
*Physical Demands and Work Environment*
The 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. Local travel may be required (5-10%).
Revian maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
Revian is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.
Work Location: In person
Compétences linguistiques
- English
Avis aux utilisateurs
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