Engineer

Career Category Operations 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. Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will support Amgen’s clinical and commercial sterile fill-finish manufacturing site in Thousand Oaks, CA. This role is ideal for an engineer with expertise in formulation and/or syringe/vial filling operations who thrives in a fast-paced manufacturing environment and can working directly on the production floor as needed to ensure reliable and compliant manufacturing execution. In this highly collaborative role, you will provide manufacturing support for aseptic processing operations, including technology transfer, process characterization, validation, deviation resolution, and continuous process verification. The position requires on-floor presence, as needed, to provide real-time manufacturing support, troubleshoot processing challenges, and drive continuous improvement initiatives that ensure the reliable supply of high-quality medicines to patients worldwide. This is a fully onsite role based in Thousand Oaks, CA and is not eligible for remote or flexible work arrangements. Due to the nature of manufacturing support activities, periodic on-call support after normal business hours and/or on weekends will be required. Manufacturing Support Lead and implement characterization studies on the floor including fill recipe development for syringes and vials, process characterization, tech transfer studies, process validation, and ongoing commercial manufacturing. Lead or assist in process related deviations, exception resolution and root cause analysis to ensure smooth operations & continued supply. Address issues with drug product processing technologies and equipment either virtually or on the floor. Conducts risk assessment for drug product operations and propose / implement appropriate CAPA for continuous improvement. Collaborate with manufacturing as well as all support functions such as engineering, quality, and drug product technologies to provide robust and coordinated support to manufacturing. Identifies and implements new process improvements for current and new sterile operations for increased reliability, agility and efficiency in plant operations. Work with multi-functional teams conducting FMEAs, risk assessments, author technical protocols, reports and CMC subsections and present findings and project status. Participate in periodic on-call support activities outside of standard working hours, including evenings, nights, and weekends, to support critical manufacturing operations and issue resolution. Aseptic DP Technology leadership Serve as SME in introducing new DP manufacturing technologies in the ATO site and work with global cross-functional teams for shared best practices in technical advancements across Amgen clinical and commercial fill-finish plants. Drive innovations in aseptic processes, technologies and techniques, all in alignment with evolving regulatory expectations and internal quality standards, leading to continuous improvement in GMP drug product manufacturing. Work individually and with a team of engineers to design, implement and document primary data packages related to new technology development, while demonstrating specific expertise in aseptic processing and unit operations characterization Supports expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in all sterile fill finish processing areas. DP Network support Establishes strong working relationships with partner sites across DP Manufacturing network to champion the sharing of technical best practices, improvement opportunities and lessons learnt to deliver high-quality manufacturing processes. Acts as Point of Contact (POC) to drug product teams to guide/knowledge of manufacturing site process capabilities and practices in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilization and inspection. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of Engineering experience OR Associate’s degree and 6 years of Engineering experience OR High school diploma / GED and 8 years of Engineering Preferred Qualifications: Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology or related technical field of study in biotechnology, life sciences or related field. 3+ years of experience in the pharmaceutical or biotechnology industry that includes elements of process development, process characterization, and technical transfers to manufacturing sites Experience in applying fundamental engineering and scientific principles to the characterization of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection. Project management skills, including the ability to handle numerous projects and evaluate project resource requirements. Demonstrated ability in providing leadership to multi-functional teams to advance complex projects to completion and influencing decisions. Ability to lead innovation, collaborate in a multi-functional team environment, and act on dynamic information at a rapid pace Ability to independently design and implement characterization studies, author characterization protocols, process transfer documents, application notes and technical reports Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with limited oversight Capable of organizing and communicating complex technical concepts to enable business decisions Solid understanding of Quality systems and Drug Product Manufacturing (GMP).s Demonstrated ability to use interpersonal skills to build strong technical relationships. Self-motivation, adaptability and a positive demeanor. Excellent communication skills, both oral and written. Ability to elevate relevant issues to project lead and line-management. Ability to