Director Engineering

About the role

As Director, Engineering at Amgen North Carolina (ANC), you will lead the site’s Engineering, Automation, Maintenance, and Instrumentation capabilities to deliver safe, compliant, reliable, and efficient drug-substance manufacturing operations. You will establish and execute the long-term technical and organizational strategy required to sustain, improve, and expand a complex GMP manufacturing operation.

Responsibilities

• Provide strategic and operational leadership for Engineering, Automation, Maintenance, and Instrumentation functions.
• Ensure safe, reliable, and compliant performance of manufacturing equipment, automation systems and instrumentation.
• Establish and execute the site asset-management strategy, including preventive maintenance, predictive maintenance, calibration, reliability, spare-parts, and lifecycle-management programs.
• Lead the engineering compliance program, maintaining inspection readiness and ensuring adherence to cGMP, EHS, quality-system, and applicable regulatory requirements.
• Partner with Site Operations, Quality, Digital/Automation, Supply Chain, and Capital Project Delivery to integrate new assets, resolve technical risks, and implement the long-term site operating strategy.
• Lead technical support for installed systems and equipment, including system ownership, troubleshooting, root-cause analysis, reliability improvement, and sustainable corrective actions.
• Establish governance for maintenance execution and work management, including planning, scheduling, backlog management, work-order quality, contractor oversight, and performance metrics.
• Develop, manage, and forecast departmental operating and capital budgets; prioritize resources against safety, quality, supply, reliability, and lifecycle risks.
• Build and lead a high-performing organization using an appropriate mix of employees, contingent workers, and service providers.
• Set clear accountabilities, develop talent, coach leaders, and create succession plans for critical technical roles.
• Manage strategic service-provider relationships and ensure contractors perform work safely, compliantly, and to required quality standards.
• Escalate significant quality, compliance, supply, safety, and asset-reliability risks to site leadership with clear options and recommendations.
• Drive continuous improvement through data-based decision making, lean maintenance practices, digital tools, reliability engineering, and sustainability initiatives.
• Represent ANC within Amgen’s global engineering, automation, maintenance, and instrumentation networks; adopt and contribute leading practices across the network.
• Make timely, risk-based decisions and trade-offs to protect patients, employees, compliance, and supply.

Requirements

• Doctorate Degree and 4 years of Engineering experience
• OR Master’s Degree and 8 years of Engineering experience
• OR Bachelor’s Degree and 10 years of Engineering experience
• At least 4 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.

Qualifications

• 12+ years of progressive engineering, maintenance, automation, instrumentation, utilities, reliability, or asset-management experience in pharmaceutical, biotechnology, or similarly regulated manufacturing.
• 7+ years of leadership experience, including direct management of technical professionals and accountability for multi-function teams, contractors, and service providers.
• Demonstrated leadership of a site-level Engineering, Automation, Maintenance, and Instrumentation organization supporting GMP manufacturing operations.
• Proven accountability for manufacturing equipment, automation platforms, process instrumentation, clean utilities, and critical production-support systems, with measurable results in reliability, compliance, and operational performance.
• Experience leading maintenance, calibration, reliability, asset lifecycle, and spare-parts programs in a CMMS environment such as Maximo.
• Demonstrated success building technical organizations, including workforce strategy, capability development, succession planning, contractor models, and vendor governance.
• Strong record of leading through regulatory inspections, significant quality events, deviations, root-cause investigations, and CAPA implementation.
• Experience partnering with capital-project teams through design, commissioning, qualification, turnover, and operational readiness.
• Demonstrated ownership of substantial operating and capital budgets, resource plans, cost forecasts, and business cases.
• Proven ability to set technical strategy, make risk-based trade-offs, and escalate safety, quality, compliance, supply, and asset-reliability risks to senior leadership.
• Experience implementing engineering excellence, reliability, digital, sustainability, energy-efficiency, or continuous-improvement initiatives at site scale.
• Strong executive communication skills and demonstrated influence across Operations, Quality, Supply Chain, EHS, Digital/Automation, and global technical networks.
• Proficiency with Microsoft Office and enterprise systems such as Maximo or equivalent CMMS platforms.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible