Manufacturing Automation Engineer – DeltaV (GMP, Remote)

Amgen; Holly Springs (NC); On-site; USD 105,000 - 143,000; Full time

Benefits offered by this job

Remote work arrangements

Total Rewards Plan

Flexible time-off

Job summary

Amgen is seeking a Manufacturing Systems Engineer specialized in automation to support the DeltaV control system for the new FleX Batch facility. You will collaborate with automation engineers to build and maintain robust process automation systems for GMP drug substance plant operations, with a swing shift schedule.

The role emphasizes QA validation, documentation, and continuous improvement, including IV/ACO, FAT, and CAPA management, while aligning with Amgen’s standards and safety

Qualifications

• Experience with automation system design and GMP biopharma equipment.
• Knowledge of DeltaV DCS and automation lifecycle.
• Experience with validation in GxP environments.
• Strong technical writing and communication skills.

Responsibilities

• Develop and maintain the DeltaV process control system.
• Collaborate with stakeholders to define process requirements.
• Provide documentation for delivered solutions.
• Support QA in computerized systems validation.
• Perform Data Integrity Assessments (DIA).
• Support commissioning, FAT, IV/ACO.
• Drive change controls, CAPAs, and deviations.
• Prepare SOPs and cGMP documents.

Skills

DeltaV DCS

Process automation

Documentation

GxP compliance

Root cause analysis

Cross-functional teamwork

Education

Bachelor’s Degree in Engineering

Tools

OPC

Foundation Fieldbus

Profibus

Emerson DeltaV

Job description

Amgen is seeking a Manufacturing Systems Engineer specialized in automation to support the DeltaV control system for the new FleX Batch facility. You will collaborate with automation engineers to build and maintain robust process automation systems for GMP drug substance plant operations, with a swing shift schedule.

The role emphasizes QA validation, documentation, and continuous improvement, including IV/ACO, FAT, and CAPA management, while aligning with Amgen’s standards and safety