Validation Area Specialist I/II - SDF
Novo Nordisk
August 27, 2026
Full-time
On-site
Durham, NC
Operations
Role: Validation Engineer supporting pharmaceutical manufacturing at Novo Nordisk's Durham, NC 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 execute validation protocols; support change control, deviation investigations, and root cause analysis; collaborate with cross-functional teams including IT and metrology to ensure compliance with cGMP, quality standards, and regulatory requirements. Requirements: Bachelor's degree in engineering, pharmaceutical sciences, or related field; minimum 2 years validation experience in pharma or medical devices; knowledge of validation concepts, cGMP documentation, and statistical methods preferred; strong communication skills. Preferred: experience with validation equipment like temperature mapping tools, cross-functional teamwork, and problem-solving techniques. High-Value: pharmaceutical validation, equipment qualification, cGMP compliance, regulated manufacturing environment, Durham-based with up to 10% travel.