Validation Engineer I

Role: Validation Engineer I at Amgen, leading validation strategy development for manufacturing facilities, with a focus on equipment qualification, cleaning validation, and validation maintenance at the North Carolina site. Responsibilities: develop validation master plans, protocols, and reports; support commissioning, qualification, and validation of process equipment; collaborate across Manufacturing, Engineering, Quality, and Supply Chain; provide technical support for regulatory audits and inspections; ensure compliance with GMP and regulatory standards (FDA, EMA, ICH); and lead process validation activities including autoclaves and cleaning processes. Qualifications: High school diploma with 8+ years, associate’s with 6+ years, bachelor’s with 2+ years, or master’s degree in a relevant field, plus manufacturing or operations experience. Preferred skills include technical writing, validation strategy development, equipment qualification, knowledge of regulations (FDA, Eudralex), and experience with biologics manufacturing, validation protocols, and systems such as Kneat or Pi. High-value specifics: biologics, GMP, validation, equipment qualification, cleaning validation, cGMP compliance, supporting regulatory filings and audits. Work setup: not explicitly stated; likely on-site at North Carolina facility with on-call support.