Sr. Systems Engineer - Project Delivery Lead

Amgen

Senior Systems Engineer leading digital transformation of manufacturing systems at a biopharmaceutical company. The role involves implementing manufacturing IT solutions, managing capital projects, ensuring regulatory compliance, and driving automation and Industry 4.0 adoption in a regulated environment.

Responsibilities

Lead implementation and integration of manufacturing IT systems including MES, SCADA, and Industry 4.0 solutions
Develop cost estimates and budgetary projections for technology components of capital projects
Create system documentation including user requirements, design specifications, and test plans
Support system commissioning, qualification, validation, and change control activities
Ensure compliance with cGMP, data integrity, and cybersecurity requirements throughout system lifecycle

Requirements

Doctorate in Engineering, or Master's in Engineering with 2+ years manufacturing systems experience, or Bachelor's in Engineering with 4+ years experience
Advanced degree in Computer, Electrical, Mechanical, Chemical, or Biomedical Engineering preferred
Knowledge of pharmaceutical or biotech manufacturing processes, especially inspection and packaging
Experience with MES, SCADA, and Industry 4.0 manufacturing IT systems
Understanding of data integrity, cybersecurity, cGMP, and validation in regulated environments
Expertise in Rockwell software platform and manufacturing process controls
Strong project management, communication, and cross-functional collaboration skills

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Vacancy posted 2 days ago

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