Validation Area Specialist I/II - SDF

Role: Validation Specialist supporting pharmaceutical manufacturing processes at Novo Nordisk's Durham facility, focusing on low to moderate complexity validation projects for equipment like propagation, fermenters, and sterilizers. Responsibilities: perform, review, and approve validation/revalidation activities, develop and approve protocols and documents, investigate deviations, support change control, and collaborate with cross-functional teams including IT and Metrology to ensure quality and compliance. Requirements: Bachelor's degree in engineering, pharmaceutical sciences, or related field; minimum 2 years validation experience in pharma or medical devices, or equivalent experience with higher education. Preferred: experience with cGMP documentation, validation areas like sterilization or cleaning, statistical methods, validation equipment (e.g., temperature mapping), and strong communication skills. High-value: validation in manufacturing of oral treatments for type 2 diabetes, regulated under GxP, with focus on equipment validation, change management, and compliance with regulatory standards. Work setup: primarily on-site with up to 10% travel; reports to Manager, Director.