Engineer, Physical Methods – GMP Test Development

Amgen Inc.; Thousand Oaks (CA); Presencial; USD 88.000 - 119.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Stock-based long-term incentives

Discretionary annual bonus

Flexible work models where possible

Retirement and Savings Plan

Descripción de la vacante

Amgen is seeking an Engineer to lead the development, qualification, validation, transfer and lifecycle management of GMP physical test methods for combination products, devices, primary containers, and secondary packaging components. The role requires handling multiple projects, testing concepts, and collaboration with manufacturing and quality teams.

Responsibilities include developing test methods for vials and injection devices, transferring methods to manufacturing, and supporting

Formación

• Master’s degree or equivalent engineering credentials required.
• Strong communication and teamwork skills.
• Experience in biotechnology/pharmaceutical industry preferred.
• 2 years of experience in biotechnology/pharmaceutical industry.
• 2 years of experience in equipment, method, and mechanical design.
• Technical writing experience.
• Experience with machine controls (PLC/HMI) and vision systems.
• Experience using Minitab.

Responsabilidades

• Develop, qualify, validate GMP physical test methods for vials, prefilled syringes, and injection devices.
• Transfer test methods and assembly requirements to manufacturing, by developing Six Sigma processes and documentation.
• Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
• Coordinate test method development and delivery with contractors.
• Provide expert training for operation and maintenance of processes, test methods and equipment.

Conocimientos

Excellent written and verbal comm.

Ability to work in a highly matrixed 팀

2 years of experience in the biotech/​

2 years of experience in equipment,方法,

Technical writing experience

Machine controls (PLC/HMI)

Vision systems

Experience with Minitab

Experience with combination products &

Educación

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

Herramientas

SolidWorks (3D-CAD)

Minitab

Descripción del empleo

Amgen is seeking an Engineer to lead the development, qualification, validation, transfer and lifecycle management of GMP physical test methods for combination products, devices, primary containers, and secondary packaging components. The role requires handling multiple projects, testing concepts, and collaboration with manufacturing and quality teams.

Responsibilities include developing test methods for vials and injection devices, transferring methods to manufacturing, and supporting