Aseptic Fill/Finish Principal Engineer

Amgen; Thousand Oaks (CA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Retirement plan

Medical coverage

Dental coverage

Vision coverage

Life insurance

Discretionary bonus

Stock incentives

Paid time off

Job summary

Amgen is seeking a Principal Engineer to lead aseptic fill/finish development in Thousand Oaks, CA. You will steer process development for filling, lyophilization, and visual inspection, champion platform harmonization, and drive automation and AI-enabled data analytics across the drug product network.

The role requires advanced degrees with substantial industry experience and a proven ability to partner across Quality, Regulatory, and Manufacturing Operations to deliver scalable solutions.

Qualifications

• Doctorate in engineering or related field with relevant biotech/manufacturing experience.
• Advanced degree in engineering or biotech preferred.
• Strong track record in pharma development and manufacturing.

Responsibilities

• Lead aseptic filling, lyophilization, and visual inspection process development.
• Develop standardized tools to improve efficiency and harmonization.
• Collaborate with cross-functional teams for technology transfer and new product introductions.
• Advance digital tools and AI-driven analytics to optimize workflows and data interpretation.
• Prepare technical documents, reports, and regulatory submissions.

Skills

Communication

Project management

Cross-functional leadership

AI/GenAI tooling

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

JMP

Minitab

Job description

Amgen is seeking a Principal Engineer to lead aseptic fill/finish development in Thousand Oaks, CA. You will steer process development for filling, lyophilization, and visual inspection, champion platform harmonization, and drive automation and AI-enabled data analytics across the drug product network.

The role requires advanced degrees with substantial industry experience and a proven ability to partner across Quality, Regulatory, and Manufacturing Operations to deliver scalable solutions.