Principal Engineer

Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Principal EngineerWhat you will doLet’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 ResponsibilitiesLead 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 youWe are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.Basic Qualifications:Doctorate degree and 2 years of engineering or operations experienceORMaster’s degree and 4 years of engineering or operations experienceORBachelor’s degree and 6 years of engineering or operations experienceORAssociate’s degree and 10 years of engineering or operations experienceORHigh school diploma/GED and 12 years of engineering or operations experiencePreferred 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 developmentExperience in designing drug product unit operations such as freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspectionExperience in technical transfer of drug product processes to manufacturing sitesStrong skills in applying fundamental engineering and scientific principles to process designExperience in recipe development using offline (Pilot) capabilities or in the manufacturing environmentExperience 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 requirementsStrong project management and cross-functional leadership skillsExperience 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 communicationWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.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.In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Apply now and make a lasting impact with the Amgen team.careers.amgen.comIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.Application deadlineAmgen 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.SponsorshipSponsorship for this role is not guaranteed.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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 Range140,334.15USD -189,863.85 USDSummaryLocation: US - California - Thousand OaksType: Full time