Manufacturing Systems Engineer: Automation

Amgen Inc

Amgen seeks a Manufacturing Systems Engineer to develop and maintain process control systems for a new advanced drug substance manufacturing facility. The role involves designing automation solutions, supporting system validation in a GMP environment, and driving continuous improvement in a fast-paced biopharmaceutical setting.

Responsibilities

Develop and maintain process control systems on Emerson DeltaV DCS platform
Collaborate with stakeholders to synthesize process requirements and deliver automation solutions
Support computerized systems validation and data integrity assessments in GxP environments
Lead change controls, CAPAs, and deviations; support root cause analysis and troubleshooting
Drive continuous improvement initiatives for automation systems and participate in rotational on-call support

Requirements

High school diploma/GED with 8 years engineering experience, or equivalent education/experience combination
Knowledge of process control engineering and GMP biopharmaceutical automation systems
Experience with Emerson DeltaV distributed control system programming and troubleshooting
Familiarity with regulatory standards including 21 CFR Part 11, GAMP, and GMP requirements
Ability to work cross-functionally with stakeholders and interpret technical documentation
Preferred degree in Electrical, Chemical, Computer, or Biotech Engineering

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Vacancy posted 5 days ago

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