Manufacturing Specialist-Process Engineer

Career Category Manufacturing Job Description Job Description 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. Specialist, Manufacturing What you will do Let’s do this. Let’s change the world. This role will support the execution of manufacturing/quality systems such as continuous improvement, technology transfer / new product introductions, process validation, manufacturing process/procedures, risk assessments, training, and non-conformance. They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support operations. You may also serve as the primary production process owner for process support systems and assist with process ownership responsibilities on process systems. Responsibilities may include, but are not limited to: Applied Process Expertise As a document owner, initiate, revise, and approve manufacturing procedures to ensure all procedures reflect current operations. Assess process performance by; observation of floor operations, review of performance data and provide troubleshooting support. Evaluate, plan, and implement solutions for process improvement opportunities. Assist in generation of training materials and / or in providing training on scientific or technical aspects of the process. Complete risk evaluations for new processes or changes to existing processes and issue the summary reports of these evaluations. Projects and Initiatives Bring continuous improvement initiatives for cost reduction or cycle time reduction and participate in the assessment or implementation of such special projects or initiatives. Process Monitoring Support process monitoring parameters and control limits based off critical metrics and recommend improvements. Collect process-monitoring data and support the assessment of deviations. Provide support of timely process monitoring quarterly reports. Technology Transfer / New Product Introductions & Process or Equipment Modifications Participate in technology transfer / NPI process to assess requirements for documentation, materials, training, and equipment modifications. Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects. Non-Conformance and CAPA Ensure that all Non-conformance are triage within the established goal. Assist with investigations, corrective actions and NC/CAPA closure within established goal. Monitor and communicate incidents trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations. Process Validation Assist with the process validation and generation of process validation protocols and reports. Support collection and analysis of process validation data. Regulatory May participate in regulatory inspections. Change Control As manufacturing change owner, provide assessments on CCRB records impacting the