Manufacturing Specialist-Process Engineer

Role: Specialist in Manufacturing supporting Amgen's biotech production processes. Objectives include executing manufacturing and quality systems, process validation, continuous improvement, technology transfer, and process troubleshooting. Responsibilities encompass developing and revising procedures, monitoring process performance, leading process validation and change control, supporting investigations and CAPA, and participating in regulatory inspections. Qualifications: Doctorate, Master's with 2+ years, Bachelor's with 4+ years, Associate's with 8+ years, or high school diploma with 10+ years of experience in engineering, manufacturing, packaging, or quality within biopharma. Preferred skills: deep understanding of bioprocessing and manufacturing operations, lean principles, cross-functional collaboration, GMP compliance, project management, data analysis, and regulatory knowledge. Therapeutic areas include Oncology, Inflammation, and Rare Diseases, focusing on biologics and cell/gene therapies at various development stages. The role requires collaboration with technical and management teams, with no specific travel expectations stated. Work setup details are not included.