Automation Systems Engineer — GMP Biotech Plant (Remote)

Amgen; Holly Springs (NC); Hybrid; USD 105,000 - 145,000; Full time

Benefits offered by this job

Total Rewards Plan

Retirement and savings plan

Medical/dental/vision coverage

Flexible remote work arrangements

Job summary

Amgen in North Carolina seeks a Manufacturing Systems Engineer focused on automation to support the new drug substance plant. You will work with the Facilities & Engineering Automation team to deliver robust process automation for GMP operations using DeltaV DCS, while coordinating with capital projects and end-users.

The role includes owning change controls, CAPAs, deviations, validation activities, and SOP development, with a focus on safety, reliability, and continuous improvement across

Qualifications

• Degree in engineering with relevant automation experience in GMP environments.
• Experience with automation projects from design through lifecycle management.
• Familiarity with 21 CFR Part 11 and other regulated documentation.

Responsibilities

• Develop and maintain process control systems on Emerson DeltaV DCS.
• Collaborate with stakeholders to translate process requirements into automation solutions.
• Provide documentation for delivered solutions and validation activities.
• Support QA partners in computerized systems validation in a GxP environment.
• Perform Data Integrity Assessments per Amgen and industry standards.
• Drive change controls, CAPAs, and deviations for the site operations.
• Support commissioning and qualification efforts including IV/ACO in a fast-paced plant.
• Prepare SOPs and cGMP documentation.

Skills

Emerson DeltaV DCS

OPC

Foundation Fieldbus

Profibus

Automation system design

Process control engineering

GAMPs / GMPs

Technical writing

Education

Bachelor’s or Master’s Degree in Electrical/Chemical/Biotech Engineering or related field

Additional certifications in automation (preferred)

Tools

DeltaV

Job description

Amgen in North Carolina seeks a Manufacturing Systems Engineer focused on automation to support the new drug substance plant. You will work with the Facilities & Engineering Automation team to deliver robust process automation for GMP operations using DeltaV DCS, while coordinating with capital projects and end-users.

The role includes owning change controls, CAPAs, deviations, validation activities, and SOP development, with a focus on safety, reliability, and continuous improvement across