Senior Engineer

Responsibilities

• Plan, design, and execute laboratory studies related to formulation, aseptic processing, and fill/finish process development
• Leverage advanced AI technologies, including generative AI, large language models (LLMs), and in silico modeling, to accelerate research and development
• Perform complex data analysis using advanced statistical and analytical techniques
• Provide technical support for clinical and commercial manufacturing operations, including troubleshooting and root cause analysis
• Author and review technical protocols, reports, and regulatory sections for IND and marketing application submissions
• Participate in Drug Product Commercialization Teams to support pipeline products and lifecycle management
• Conduct risk assessments and implement appropriate CAPA for inspection operations

Requirements

• Doctorate Degree OR Master’s Degree with 2 years of Engineering/Operations experience OR Bachelor’s Degree with 4 years of experience
• Experience in aseptic processing and fill/finish process development
• Proficiency in statistical analysis and data science principles
• Knowledge of cGMP manufacturing environments and regulatory requirements
• Experience working with generative AI and large language models (LLMs)

Preferred Qualifications

• Experience in new product development, equipment design, and technical transfers to global manufacturing sites
• Proficiency in digital technologies, automation systems, and process monitoring tools
• Advanced degree in Chemical Engineering, Biomedical Engineering, Biotechnology, or Pharmaceutics
• Strong project management skills and ability to lead cross-functional teams

Benefits

• Comprehensive health and welfare plans, including medical, dental, and vision coverage
• Retirement and Savings Plan with generous company contributions
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, Amgen has pioneered advancements in oncology, inflammation, general medicine, and rare diseases, leveraging biologics manufacturing expertise to deliver innovative human therapeutics worldwide.