Validation Engineer

We are seeking an experienced Validation Engineer with strong project engineering skills to support a critical manufacturing change for a medical device product. This is a highly cross‑functional role focused on both project management (approximately 70%) and hands‑on validation engineering (approximately 30%) . The project involves a change in suture manufacturing, specifically transitioning how a sterilization agent is incorporated into the product. This role will be instrumental in developing and executing validation strategies from the ground up while coordinating closely with R&D, Quality, and Operations. Key Responsibilities Project & Program Management (Primary Focus): Lead and manage a complex manufacturing change project from validation planning through execution. Drive change control activities, ensuring documentation, redlines, and approvals are current and compliant. Coordinate cross‑functional responsibilities, timelines, and deliverables across Operations, Quality, and R&D. Ensure appropriate sampling strategies, documentation readiness, and hold points are clearly defined and followed. Communicate project status, risks, and mitigation plans to stakeholders. Validation Engineering: Develop validation strategies and author validation documentation from scratch, including IQ, OQ, and PQ . Execute validation activities in a regulated medical device manufacturing environment. Review and assess manufacturing processes and procured equipment to determine validation requirements. Analyze validation data and compile final reports in compliance with regulatory and quality standards. Partner closely with Quality to ensure validation approaches meet internal and external requirements. Cross‑Functional Collaboration Work closely with internal R&D teams located at multiple U.S. sites to ensure alignment between manufacturing execution and development intent. Serve as a bridge between manufacturing sites and R&D, ensuring feedback and data are communicated effectively. Collaborate with Operations and Quality teams to support seamless implementation of manufacturing changes. Required Qualifications Bachelor's degree in Engineering or a related technical discipline. 5+ years of experience in validation engineering within a medical device or highly regulated environment. Strong working knowledge of IQ/OQ/PQ development, execution, and reporting. Experience managing manufacturing changes and associated validation activities. Demonstrated ability to lead projects, manage timelines, and coordinate cross‑functional teams. Excellent documentation, communication, and organizational skills. Preferred Background Combination of Project Manager or Project Engineer experience with a solid validation foundation. Experience authoring validation protocols that did not previously exist. Ability to work independently and drive initiatives with minimal oversight. Comfortable balancing hands‑on technical work with high‑level project oversight. Hybrid work model: one week onsite followed by one week remote . Interview panel includes the hiring manager and Quality representation. Opportunity to contribute to a high‑impact manufacturing transformation in a fast‑paced medical device environment. EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #J-18808-Ljbffr