Engineer I

Role: Support manufacturing activities at Amgen’s Thousand Oaks site, focusing on cGMP equipment and facilities for biologics production. Responsibilities include ensuring equipment performance and reliability, supporting capital projects, and driving safety and quality compliance; providing technical support and oversight during validation, commissioning, and continuous improvement initiatives. Collaboration involves engineering, automation, maintenance, quality assurance, and project teams. Requirements: Master’s degree or Bachelor's with 2+ years’ engineering/manufacturing experience; preferred experience in regulated biotech/pharma environments, cGMP procedures, and process automation systems (e.g., Delta V, Rockwell). Qualifications: Knowledge of biologics manufacturing processes (cell culture, fermentation, purification), validation protocols, and risk-based verification approaches; strong communication and teamwork skills; familiarity with process improvement methodologies (LEAN, Six Sigma). The role emphasizes compliance with FDA and other regulatory standards, supporting the development and optimization of manufacturing systems for biologics. Location: Thousand Oaks, CA. The position involves cross-functional collaboration, validation oversight, and process improvements within a regulated biotech manufacturing setting.