Senior Engineer - Downstream Bioprocess Leader

BioSpace; Thousand Oaks (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Amgen is seeking a Senior Engineer to lead downstream purification operations across clinical and commercial biologics. You will provide technical leadership, oversee technology transfer, and drive process optimization in a fast-paced manufacturing environment.

You will mentor engineers, collaborate with Manufacturing, Quality, Process Development, and Regulatory teams, and ensure compliance with cGMP standards while supporting deviations, investigations, and CAPAs.

Qualifications

• Doctorate degree required.
• Master’s degree with 2+ years of engineering experience.
• Bachelor’s degree with 4+ years of engineering experience.
• Associates degree with 8 years of engineering experience.
• High school diploma / GED and 10 years of engineering experience.

Responsibilities

• Provide engineering oversight for downstream purification manufacturing and tech transfer across clinical and commercial biologics.
• Lead cross-functional teams through process development, technology transfer, and manufacturing support.
• Oversee production facilities operations including process execution, equipment utilization, and optimization.
• Mentor and develop downstream process engineers; guide investigations and CAPAs.
• Collaborate with Manufacturing, Quality, Process Development, Validation, Regulatory, Supply Chain, and network teams to deliver technical solutions.

Skills

Leadership

Cross-functional teamwork

Problem solving

Mentoring

Education

Doctorate degree

Master’s degree in Engineering

Bachelor’s degree in Engineering

Associates degree in Engineering

High school diploma / GED + 10 years engineering experience

Job description

Amgen is seeking a Senior Engineer to lead downstream purification operations across clinical and commercial biologics. You will provide technical leadership, oversee technology transfer, and drive process optimization in a fast-paced manufacturing environment.

You will mentor engineers, collaborate with Manufacturing, Quality, Process Development, and Regulatory teams, and ensure compliance with cGMP standards while supporting deviations, investigations, and CAPAs.