Senior Validation Engineer (Raleigh, NC)

Eupry•Raleigh, NC

16h•Onsite

About The Position

As a Senior Validation Engineer, you will be the technical and operational backbone of our CQV service delivery. You will take ownership of client-facing validation projects from scoping to final reporting, ensuring that complex temperature mapping strategies are executed flawlessly. You will act as a technical subject matter expert and work directly with international colleagues to align our activities across global markets. You will act as a key partner in our global validation activities, ensuring that every project meets the highest standards of GxP compliance.

Requirements

Experienced: You have a solid background in GxP temperature mapping within the Life Science industry, with a proven track record.
Project Driven: You are a skilled project manager who enjoys the challenge of managing multiple stakeholders, technical requirements, and deadlines.
Technically Sharp: You have a strong understanding of GxP, GDP, and the regulatory requirements surrounding environmental monitoring and storage.
Communicative: You are comfortable interacting with clients and can translate technical requirements into actionable project plans.
Analytical: You have an eye for detail and a commitment to data integrity and documentation excellence.
Comfortable working in scale-up or agile environments
Fluent in English (spoken and written)
Willingness to travel on business trips—primarily within United States

Responsibilities

Project Ownership & Execution: Independently manage and execute the end-to-end lifecycle of CQV projects for pharmaceutical and logistics clients.
Technical Excellence: Drive the strategy and execution of temperature mapping activities for warehouses, Temperature Controlled Units (TCUs), and cold chain transport.
Project Management: Plan, coordinate, and prioritize resources and timelines to ensure projects are delivered on time, within scope, and at the highest quality.
Documentation & Compliance: Develop, execute, and review high-quality qualification protocols (IQ/OQ/PQ) and summary reports in strict alignment with GMP, GxP, and USP <1079> / ISO standards.
Client Consultancy: Serve as a technical point of contact for clients, providing guidance on regulatory expectations and validation best practices throughout the project lifecycle.
Process Improvement: Support the improvement of internal thermal mapping procedures and documentation templates to support scalability and technical accuracy.
Cross-functional Collaboration: Work closely with R&D, QA, and Customer Success to ensure our IoT solutions are seamlessly integrated into the client’s validation framework.
Technical Support: Provide technical guidance and peer-review for other validation team members to maintain high delivery standards.