GMP Process Test Engineer - Remote

Amgen; Thousand Oaks (CA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking an Engineer to support the development, qualification and validation of GMP test methods for vials, prefilled syringes and injection devices. You will coordinate with contractors, ensure design verification and qualification, and assist with CAPA and risk assessment to strengthen manufacturing processes.

The role requires a Master’s degree in engineering and at least one year of related experience, with familiarity across GMP, GDP, ISO standards, and industry tools like SAP,

Qualifications

• Master’s degree in Mechanical, Biomedical, Electrical Engineering or related field and 1 year relevant experience.
• Knowledge of ASME Y14.5, ISO standards, and CFRs in regulated biopharmaceutical environments.
• Experience with GMP, GDP or GEP as they apply to manufacturing processes, facilities, or equipment.
• Familiarity with SAP, Trackwise, Minitab, Maximo, Smartsheet; design/prototyping tools like SolidWorks/GrabCAD/Polyjet.
• Experience validating protocols and documentation following change control and CAPA processes.

Responsibilities

• Support development, qualification and validation of GMP test methods for vials, syringes and injection devices.
• Coordinate test method development, design characterization, verification and delivery with contractors.
• Assist in risk assessment, CAPA, investigation support and change control for process improvements.
• Prepare and review documentation per GDP and quality systems; ensure timely project lifecycle execution.

Skills

GMP knowledge

ASME Y14.5 familiarity

GEP/GDP understanding

Problem solving

Education

Master’s degree in Mechanical/Biomedical/Electrical Engineering or related field

Tools

SAP

Trackwise

Minitab

Maximo

Smartsheet

SolidWorks

GrabCAD

Polyjet 3D Printing

Job description

Amgen is seeking an Engineer to support the development, qualification and validation of GMP test methods for vials, prefilled syringes and injection devices. You will coordinate with contractors, ensure design verification and qualification, and assist with CAPA and risk assessment to strengthen manufacturing processes.

The role requires a Master’s degree in engineering and at least one year of related experience, with familiarity across GMP, GDP, ISO standards, and industry tools like SAP,