Principal Engineer

Amgen Inc.; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Flexible work models

Job summary

Amgen Inc. in Thousand Oaks, CA seeks a Principal Engineer to lead aseptic fill/finish development, characterization, and platform harmonization for late-stage biologics. You will drive process development strategy, automation, and data-driven decision making across global tech transfers.

The role requires deep expertise in E2E aseptic manufacturing and cross-functional leadership to deliver scalable solutions. Travel up to 10% to domestic and international sites may be required.

Qualifications

• Doctorate or other degree with relevant experience in engineering/operations.
• Advanced degrees with pharmaceutical development/manufacturing experience.
• Experience in drug product unit operations and tech transfer.

Responsibilities

• Lead design and execution of process development for aseptic filling, lyophilization, and visual inspection.
• Develop tools to improve business-process efficiency and harmonization.
• Partner with SMEs to advance activities and enable technology transfers.
• Collaborate across drug product manufacturing network for characterization and recipe development.
• Identify and implement process improvements and provide technical support.
• Analyze data with advanced statistical methods and software.
• Support clinical and commercial fill/finish manufacturing with CAPA and investigations.
• Apply and advance in silico modeling tools.
• Prepare guidance documents, protocols, and regulatory submissions.
• Provide progress reports to management and stakeholders.

Skills

Aseptic processing

Process development

Cross-functional leadership

Data analytics

AI/GenAI in manufacturing

Statistical thinking

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

JMP

Minitab

Digital process control systems

Job description

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.

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.

What we expect of you

Basic Qualifications

• Doctorate degree and 2 years of engineering or operations experience
• Master’s degree and 4 years of engineering or operations experience
• Bachelor’s degree and 6 years of engineering or operations experience
• Associate’s degree and 10 years of engineering or operations experience
• 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

What you can expect of us

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range

140,334.15USD -189,863.85 USD