Principal Engineer

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.

Key Responsibilities

• 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.

Basic Qualifications

• Doctorate degree and 2 years of engineering or operations experience OR
• Master’s degree and 4 years of engineering or operations experience OR
• Bachelor’s degree and 6 years of engineering or operations experience OR
• Associate’s degree and 10 years of engineering or operations experience OR
• High school diploma/GED and 12 years of engineering or operations experience

Preferred Qualifications

• Advanced degree in Engineering, Biotechnology, Pharmaceutics or related discipline with experience in pharmaceutical development and manufacturing.
• 5+ years of relevant experience in pharmaceutical/biotech development
• Experience in designing drug product unit operations such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection
• Experience in technical transfer of drug product processes to manufacturing sites
• Strong skills in applying fundamental engineering and scientific principles to process design
• Experience in recipe development using offline (Pilot) capabilities or in the manufacturing environment
• Experience leveraging Artificial Intelligence (AI) and Generative AI (GenAI) tools to drive automation, enhance data analysis, optimize workflows, and develop AI-powered solutions for business and operational efficiency.
• Proficiency in digital technologies and automation systems related to aseptic processing and filling operations, including experience with data analytics, process monitoring tools, and digital process control systems.
• Proven experience with Process tech transfer, Process characterization and validation
• Statistical software (e.g., JMP, Minitab)
• Familiarity with FDA/EU GMP standards, global regulatory requirements
• Strong project management and cross-functional leadership skills
• Experience that includes elements of new product development, aseptic processing, filling, lyophilization, manual / automated visual inspection, process characterization, equipment design and implementation, technical transfers to global manufacturing sites, statistical process control (SPC), and statistical design and analysis of experiments.
• Proven ability to learn and act on dynamic information at a rapid pace.
• Excellent written and verbal communication