Senior Engineer

About the role

At Amgen, the Senior 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.

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.
• May lead cross-site teams to support the above activities, providing recommendations to management.
• Develops Validation Plans, IOQs and PQs.
• Ensures that inspection operations meet applicable quality requirements applicable laws FDA, EU & International Standards.
• Aids in deviation and exception resolution and root cause analysis.
• Coordinates and organizes resources needed to complete tasks.

Requirements

• Doctorate Degree OR Masters Degree and 2 years of Engineering and/or Operations experience OR Bachelors Degree and 4 years of Engineering and/or Operations experience OR Associates degree and 8 years of Engineering and/or Operations experience OR High school diploma/GED and 10 years of Engineering and/or Operations experience

Qualifications

• PhD with 2 years of industry experience preferred.
• Background industry with development and manufacturing visual inspection experience preferred.
• Experience with Knapp studies preferred.
• Experience in packaging and inspection equipment preferred.
• Previous experience with Pharma inspection background preferred.

Benefits

We offer 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. Additionally, we provide a discretionary annual bonus program, stock-based long-term incentives, and award-winning time-off plans.

Pay

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.

Schedule

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