Biotech GMP Automation Engineer

Amgen Inc. (IR); Holly Springs (NC); Hybrid; USD 105,000 - 143,000; Full time

Benefits offered by this job

Benefits package

Bonus program

Stock incentives

Flexible work models

Job summary

Amgen is seeking a Manufacturing Systems Engineer focused on Automation to join the Facilities & Engineering (F&E) Automation team. You will work with automation engineers to build and maintain control systems for the new drug substance plant, delivering robust process automation that aligns with Amgen specifications and safety requirements.

The role involves collaboration with capital projects, documentation, and support for commissioning, validation, and continuous improvement in a GMP

Qualifications

• Degree in engineering with GMP/biopharma exposure.
• Strong technical writing and communication skills.
• Experience in automation system design and troubleshooting.

Responsibilities

• Develop and maintain process control on DeltaV DCS in GMP setting.
• Collaborate with stakeholders to translate process requirements into automation solutions.
• Provide documentation and support QA in validation activities (GxP).
• Support FAT, IV/CO, and change control processes.
• Drive continuous improvement of automation systems for efficiency and safety.

Skills

GMP knowledge

Technical writing

Cross-functional collaboration

Process automation

Education

Bachelor's Degree in Engineering

Master's Degree

Tools

Emerson DeltaV DCS

OPC

Foundation Fieldbus

Profibus

Job description

Amgen is seeking a Manufacturing Systems Engineer focused on Automation to join the Facilities & Engineering (F&E) Automation team. You will work with automation engineers to build and maintain control systems for the new drug substance plant, delivering robust process automation that aligns with Amgen specifications and safety requirements.

The role involves collaboration with capital projects, documentation, and support for commissioning, validation, and continuous improvement in a GMP