Senior Engineer

Senior Engineer What you will do

As part of the Drug Product Technologies group, this role oversees late‑stage biologics drug product formulation and fill/finish process development for large molecule, RNA, and virus modalities. The Senior Engineer will be 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, and applying emerging AI technologies to drive innovation.

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

• Serve as the technical SME for visual inspection and lead troubleshooting of complex inspection issues.
• Participate in Drug Product Commercialization Teams and support lifecycle management of commercial products.
• Own and continuously improve the defect kit preparation and management process supporting visual inspection development studies.
• Establish testing strategies and develop characterization protocols, offline testing methods, and product quality impact assessments.
• Interface with inspection teams across Amgen manufacturing sites to communicate site capabilities, best practices, and lessons learned.
• Leverage advanced AI technologies, including generative AI and LLMs, to accelerate research, development, and testing.
• Plan, design, execute, and document laboratory studies related to formulation, aseptic processing, visual inspection, and fill/finish process development.
• Apply basic science/engineering skills and first‑principles modeling to resolve technical problems.
• Perform data analysis using advanced statistical techniques with proficiency in statistical analysis software.
• Provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, root‑cause analysis, and product impact assessment for deviations and process improvements.
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections for IND and marketing application submissions.
• Deliver progress reports and presentations to keep management informed of program status and future needs.
• Conduct risk assessments for inspection operations and implement CAPA.
• Identify and implement operational opportunities for current and new inspection operations.
• Lead cross‑site teams to support these activities and provide recommendations to management.
• Develop Validation Plans, IQOs, and PQs.
• Ensure inspection operations meet applicable quality requirements (FDA, EU, and International Standards).
• Assist in deviation and exception resolution and root‑cause analysis.
• Coordinate and organize resources needed to complete tasks.

Basic Qualifications:

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

Preferred Qualifications:

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

The role offers a competitive salary and a comprehensive Total Rewards Plan, including health and welfare benefits, a retirement savings plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, a discretionary bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where applicable.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will provide reasonable accommodations for individuals with disabilities throughout the application or interview process.