Principal Engineer

Let’s do this. Let’s change the world. In this vital role you will join the Drug Product Technologies (DPT) group to join our Thousand Oaks, CA team. This role is responsible for the development, characterization, and technology leadership of aseptic fill/finish operations , including Filling, Lyophilization and visual inspection systems , and in maturing our platforms ecosystem supporting late-stage drug product programs across biologic modalities.

The Principal Engineer will need to stay ahead of the latest developments/trends in the industry and scientific community to foster innovation and to meet future business needs. The position requires deep expertise in E2E aseptic manufacturing technologies , and process development strategy , with an emphasis on platform harmonization , simplification, automation, and data-driven decision making. The Principal Engineer will provide technical and strategic leadership while integrating cross-functional information to ensure success throughout the product lifecycle, from process characterization to commercialization and global tech transfers.

The successful candidate will operate in a fast-paced, matrixed environment , collaborating across Drug Product Technologies, Quality, Regulatory, and Manufacturing Operations. They will be accountable for advancing technical solutions, driving innovation, and improving operational efficiency across the network. A successful candidate will be self-motivated , able to manage complex work packages, and excel at influencing across teams. They will also bring a forward-looking mindset—staying ahead of trends and technology to shape the future of drug product development at Amgen.

This position requires up to 10% travel to domestic and international sites.

• Lead the design and execution of process development for aseptic filling, lyophilization, and visual inspection.
• Apply comprehensive knowledge of process and product commercialization to develop and standardize tools that improve business-process efficiency and harmonization, including study designs, prior-knowledge assessments, lessons learned, and protocol and report templates.
• Partner with unit operation owners and subject matter experts to advance these activities.
• Partner with cross-functional subject matter experts across the drug product manufacturing network to execute filling, lyophilization, and visual inspection characterization and recipe development, enabling technology transfers and new product introductions across clinical and commercial manufacturing sites.
• Collaborate across functions to identify and implement process improvements, provide technical support, and facilitate knowledge sharing across sites.
• Analyze data using advanced statistical and analytical techniques and statistical software.
• Support clinical and commercial fill/finish manufacturing, as needed, through process capability analysis, troubleshooting, root-cause analysis, and product impact assessments for nonconformance investigations and process changes or improvements.
• Apply and advance in silico modeling tools.
• Author and review guidance documents, technical protocols and reports, product impact assessments, and regulatory sections supporting IND and marketing application submissions.
• Provide progress reports and presentations that keep management informed and engaged on program status, advancement, and future functional needs.
• Periodically support the authorship of manuscripts and technical articles, departmental workshops, and evaluations of offline capabilities.

• Doctorate degree and 2 years of engineering or operations experience
• Master’s degree and 4 years of engineering or operations experience
• Bache…