Specialist Manufacturing – Cleaning Validation

Role: Specialist Manufacturing – Cleaning Validation within Amgen’s Drug Substance Supply supporting multi-product biologics manufacturing. Objectives: Lead equipment cleanability assessments and validation activities to ensure compliance and product quality. Responsibilities: own validation requirements for NPIs and existing products, lead cross-functional projects from planning to execution, provide technical support during manufacturing and troubleshooting, develop validation strategies and documentation, support commissioning and audits, monitor validation status, and serve as a SME during regulatory inspections. Qualifications: Doctorate or Master's with 2+ years, Bachelor's with 4+ years, or equivalent GMP validation/engineering experience; strong technical, data analysis, and communication skills. Preferred: experience in biologics manufacturing, equipment validation, regulatory submissions, and GxP standards (e.g., FDA 21 CFR Parts 210/211, EudraLex Annex 15). High-value: biologics (likely recombinant or cell therapy), validation for sterile equipment and cleaning processes, supporting both clinical and commercial phases, cross-functional collaboration across Quality, Engineering, Manufacturing, and Supply Chain. Work setup: on-site with flexible hours, including weekends and holidays, to align with manufacturing schedules.