Engineer, Physical Test Methods – GMP Devices (Flexible Work)

Amgen; Thousand Oaks (CA); On-site; USD 88,000 - 119,000; Full time

Benefits offered by this job

Stock-based incentives

Retirement and Savings Plan

Flexible work models

Discretionary annual bonus

Job summary

Amgen seeks an experienced engineer to develop and validate GMP physical test methods for vials, devices, and packaging. You will lead method transfer to manufacturing and QA, coordinating cross-functional teams to ensure quality and efficiency.

The role requires strong communication, project management, and experience with validation, quality systems, and data analysis. Travel up to 10% may be required.

Qualifications

• Master’s degree or higher in engineering or related field.
• Strong communication and cross-functional teamwork skills.
• Experience with GMP, validation, and quality controls.
• Proven ability to design, qualify, validate, and transfer test methods.

Responsibilities

• Develop, qualify, validate GMP physical test methods for products and packaging.
• Coordinate transfer of methods to manufacturing and QA teams.
• Lead cross-functional collaborations to meet project timelines.
• Support investigations and CAPA activities for process improvements.
• Provide training on new methods and equipment.
• Travel ~10% to support international locations.

Skills

Mechanical Engineering

Biomedical Engineering

Test method development

Quality systems

Education

Master’s degree

Bachelor’s degree + 2 years of Engineering experience

Associate’s degree + 6 years of Engineering

High school diploma / GED + 8 years of Engineering experience

Tools

SolidWorks

Minitab

PLC/HMI

Vision systems

Job description

Amgen seeks an experienced engineer to develop and validate GMP physical test methods for vials, devices, and packaging. You will lead method transfer to manufacturing and QA, coordinating cross-functional teams to ensure quality and efficiency.

The role requires strong communication, project management, and experience with validation, quality systems, and data analysis. Travel up to 10% may be required.