Director of Engineering, GMP Biotech Ops (Remote)

Amgen; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Amgen North Carolina is seeking a Director, Engineering to lead the site’s Engineering, Automation, Maintenance, and Instrumentation capabilities, delivering safe, compliant, and efficient drug-substance manufacturing. You will set long-term technical strategy, balance safety and quality with asset reliability, and guide a high-performing team.

The role requires substantial leadership in GMP environments, with responsibilities spanning governance, risk management, and collaboration with

Qualifications

• Doctorate/Master/Bachelor with required years of engineering experience and leadership.
• Experience leading GMP manufacturing operations and compliance.
• Proven ability to manage budgets, resources, and capital projects.
• Strong executive communication and cross-functional influence.

Responsibilities

• Provide strategic and operational leadership for Engineering, Automation, Maintenance, and Instrumentation functions.
• Ensure safe, reliable, and compliant performance of manufacturing equipment and systems.
• Establish and execute site asset-management, preventive and predictive maintenance programs.
• Lead the engineering compliance program and maintain inspection readiness for cGMP and regulatory requirements.
• Partner with operations, Quality, Digital/Automation, Supply Chain to integrate new assets and manage risks.
• Lead technical support for installed systems, troubleshooting, and reliability improvement.
• Govern maintenance execution, planning, scheduling, and contractor oversight.

Skills

Leadership

Cross-functional collaboration

Strategic planning

Education

Doctorate in Engineering

Master’s in Engineering

Bachelor’s in Engineering

Tools

Maximo CMMS

Microsoft Office

Job description

Amgen North Carolina is seeking a Director, Engineering to lead the site’s Engineering, Automation, Maintenance, and Instrumentation capabilities, delivering safe, compliant, and efficient drug-substance manufacturing. You will set long-term technical strategy, balance safety and quality with asset reliability, and guide a high-performing team.

The role requires substantial leadership in GMP environments, with responsibilities spanning governance, risk management, and collaboration with