Engineer - F&E Environmental & Contamination Control

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity‑related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Engineer, F&E Environmental & Contamination Control What you will do Let’s do this. Let’s change the world. In this vital role you will report to the Facilities & Engineering organization and serve as a technical deviation owner or Functional area owner responsible for investigating and resolving equipment, utility, automation, facility, commissioning, qualification, and project‑related quality events. The Engineering Deviation Owner and/or functional area owner is accountable for the end‑to‑end management of assigned deviation records, ensuring investigations are technically sound, scientifically justified, inspection‑ready, and completed in accordance with site procedures and regulatory expectations. Responsibilities Deviation Ownership & Execution Demonstrated technical writer capable of translating complex engineering, equipment, automation, utility, and project‑related events into concise, technically accurate, and inspection‑ready documentation. Independently drive deviation investigations from initiation through closure while ensuring compliance with site procedures and quality system requirements. Maintain accountability for record quality, data integrity, technical accuracy, and timely progression of assigned deviations. Prioritize and manage multiple investigations simultaneously in a dynamic manufacturing environment. Technical Investigation & Root Cause Analysis Develop and execute investigation strategies for equipment, utility, facility, automation, commissioning, qualification, and manufacturing support events. Conduct field assessments, equipment walkdowns, system reviews, and Genba activities to gather factual evidence. Utilize engineering problem‑solving methodologies to determine root cause and contributing factors. Lead structured Root Cause Analysis (RCA) sessions involving cross‑functional stakeholders. Evaluate potential impacts to validated systems, product quality, operational reliability, and compliance. Corrective and Preventive Actions (CAPA) Develop technically robust corrective and preventive actions aligned with investigation outcomes. Ensure CAPAs address both immediate causes and systemic contributors. Support effectiveness verification activities and long‑term monitoring strategies. Identify opportunities to improve equipment reliability, utility performance, maintenance practices, and engineering processes. Cross-Functional Collaboration Partner with Manufacturing, Quality Assurance, Quality Control, Automation, Maintenance, Facilities, Engineering Technical Authorities (ETA), Process Development, Capital Projects, and Global Engineering organizations. Facilitate alignment among stakeholders and drive timely technical decision‑making. Ensure appropriate SME engagement and challenge assumptions through data‑driven discussions. Documentation & Technical Decision Making Develop investigation narratives and technical assessments that clearly communicate event chronology, causal analysis, risk assessments, and conclusions. Support impact assessments associated with: Equipment modifications Utility system changes Automation updates Commissioning and qualification activities Capital project implementation Ensure documentation meets Quality Management System (QMS) requirements and inspection expectations. Regulatory & Inspection Readiness Serve as a Subject Matter Expert (SME) during regulatory inspections and internal audits```json { #J-18808-Ljbffr Amgen SA