Engineer

Role: Support sterile fill-finish manufacturing at Amgen's Thousand Oaks site, focusing on aseptic processing, process characterization, technology transfer, validation, and continuous improvement to ensure reliable production of biologic medicines. Responsibilities include leading characterization studies, troubleshooting deviations, implementing risk assessments and CAPA, and collaborating with cross-functional teams (engineering, quality, drug product tech) to optimize processes. The role also involves serving as SME for new aseptic technologies, supporting expansion projects, and establishing strong network relationships across manufacturing sites. Requirements: Master's degree or equivalent experience (e.g., Bachelor's + 2 years engineering, Associate's + 6 years, or high school + 8 years). Preferred qualifications include 3+ years in biopharma processes such as fill/finish, formulation, lyophilization, or related fields, with expertise in GMP, sterile manufacturing, and process development. Skills in project management, technical problem-solving, process validation, and cross-functional communication are essential. The position requires onsite presence, periodic on-call support outside regular hours, and is suited for candidates with a background in chemical, biomedical engineering, or biotech, with prior experience in biologics manufacturing and aseptic processes.