Aseptic Fill/Finish Engineering Leader

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

Benefits offered by this job

Discretionary annual bonus

Stock-based long-term incentives

Flexible work models

Job summary

Amgen Inc. in Thousand Oaks, CA seeks a Principal Engineer to lead aseptic fill/finish development, characterization, and platform harmonization for late-stage biologics. You will drive process development strategy, automation, and data-driven decision making across global tech transfers.

The role requires deep expertise in E2E aseptic manufacturing and cross-functional leadership to deliver scalable solutions. Travel up to 10% to domestic and international sites may be required.

Qualifications

• Doctorate or other degree with relevant experience in engineering/operations.
• Advanced degrees with pharmaceutical development/manufacturing experience.
• Experience in drug product unit operations and tech transfer.

Responsibilities

• Lead design and execution of process development for aseptic filling, lyophilization, and visual inspection.
• Develop tools to improve business-process efficiency and harmonization.
• Partner with SMEs to advance activities and enable technology transfers.
• Collaborate across drug product manufacturing network for characterization and recipe development.
• Identify and implement process improvements and provide technical support.
• Analyze data with advanced statistical methods and software.
• Support clinical and commercial fill/finish manufacturing with CAPA and investigations.
• Apply and advance in silico modeling tools.
• Prepare guidance documents, protocols, and regulatory submissions.
• Provide progress reports to management and stakeholders.

Skills

Aseptic processing

Process development

Cross-functional leadership

Data analytics

AI/GenAI in manufacturing

Statistical thinking

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma/GED

Tools

JMP

Minitab

Digital process control systems

Job description

Amgen Inc. in Thousand Oaks, CA seeks a Principal Engineer to lead aseptic fill/finish development, characterization, and platform harmonization for late-stage biologics. You will drive process development strategy, automation, and data-driven decision making across global tech transfers.

The role requires deep expertise in E2E aseptic manufacturing and cross-functional leadership to deliver scalable solutions. Travel up to 10% to domestic and international sites may be required.