Senior Engineer

Amgen • Thousand Oaks, CA

4d • Onsite

About The Position

Join Amgen’s Mission of Serving Patients At 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Senior Engineer What you will do Let’s do this. Let’s change the world. As part of the Drug Product Technologies group, we are seeking a Senior Engineer based in Thousand Oaks, CA. This group is responsible for late-stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). The Sr. Engineer will provide technical leadership and subject matter expertise supporting biologics drug product development, commercialization, and lifecycle management. This role serves as the visual inspection technical expert across manual, semi-automated, and automated inspection platforms, partnering with cross-functional teams to develop robust inspection strategies for pipeline and commercial products. The successful candidate will leverage scientific expertise, data analytics, digital technologies, and emerging AI-enabled capabilities to advance inspection practices and accelerate development activities. Further, the candidate 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 Sr Engineer will Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes to advance Amgen practices and ensure success through the commercialization process. The candidate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product and process development. The Sr Engineer will operate in a fast-paced, matrixed environment and collaborate successfully with colleagues within DPT and cross-functionally to develop and proceduralize lean study designs for process characterization, create and implement tools for data acquisition, analysis, and modeling, and improve operational efficiency via alignment of work across teams, and tailoring output to intended user requirements. A successful candidate will be able to work independently, taking responsibility of projects and self-managing their work packages with appropriate communication and escalation. A successful candidate will thrive in a multi-functional team environment, adeptly collaborating and liaising with colleagues within the function, as well as partner organizations across Operations. Finally, a successful candidate will be driven to find efficient approaches to solve relevant problems and will thereby deliver value-adding and agile solutions to Amgen Process Development. This position requires (up to 10%) travel to domestic and international sites

Requirements

• Doctorate Degree OR Master’s Degree and 2 years of Engineering and/or Operations experience OR Bachelor’s Degree and 4 years of Engineering and/or Operations experience OR Associate’s degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 10 years of Engineering and/or Operations experience

Nice To Haves

• Doctorate Degree OR Master’s Degree and 2 years of Engineering and/or Operations experience OR Bachelor’s Degree and 4 years of Engineering and/or Operations experience OR Associate’s degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 10 years of Engineering and/or Operations experience

Responsibilities

• Serve as the technical SME for visual inspection and provide leadership in troubleshooting complex inspection-related issues.
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management.
• Own and continuously improve the business process for defect kit preparation and management supporting visual inspection development studies.
• Establish testing strategies and develop characterization protocols, offline testing methods, and product quality impact assessments for product teams.
• Interface with inspection teams across Amgen manufacturing sites and communicate site capabilities, best practices, and lessons learned.
• Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to drive innovation and accelerate research, development, and testing processes
• Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection and fill/finish process development in support of product commercialization and life cycle management
• Apply basic science/engineering skills and first principles modeling to solve technical problems
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software.
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions.
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs.
• Conducts risk assessment for inspection operations and propose / implement appropriate CAPA.
• Identifies and implements operational opportunities for current and new inspection operations.
• Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
• Development of Validation Plans, IOQs and PQs
• Ensure that inspection operations meet applicable quality requirements applicable laws FDA, EU & International Standards
• Assist in deviation and exception resolution and root cause analysis.
• Coordinates and organizes resources needed to complete tasks

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree