Senior Automation & PLC Systems Engineer — GMP Biotech

BioSpace

Holly Springs (NC)

On-site

USD 110,000 - 160,000

Full time

7 days ago

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Job summary

Amgen seeks a Senior Manufacturing Systems Engineer: Automation PLC to lead automation engineering for the new drug substance manufacturing plant. You will architect, implement, and sustain PLC/SCADA/HMI solutions to support GMP operations.

You will collaborate with capital projects and process SMEs to deliver robust automation, drive improvements, and ensure compliance with 21 CFR Part 11 and related standards. This role requires strong leadership and cross-functional collaboration.

Qualifications

Basic qualifications include a degree in engineering and multiple years of engineering experience or an advanced degree with fewer years of experience.
Experience with automation platforms, control systems, and lifecycle management in a GMP biopharma setting is preferred.
Ability to lead automation projects, perform troubleshooting, and provide technical guidance to the automation team.

Responsibilities

Provide automation technical leadership to engineers for GMP drug substance plant operations.
Collaborate with capital projects to deliver robust automation systems.
Lead standalone system implementation, startup, and validation activities in a regulated environment.
Develop and maintain PLC, SCADA, HMI, and interface hardware.
Drive continuous improvements for efficiency, safety, and sustainability.
Create documentation and support QA during computerized systems validation.