Director Engineering

BioSpace; Holly Springs (NC); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Flexible work models

Stock-based incentives

Job summary

Amgen North Carolina is seeking a Director of Engineering to lead Engineering, Automation, Maintenance, and Instrumentation, delivering safe, compliant, reliable, and efficient drug-substance manufacturing operations. You will shape the long-term technical strategy and grow a high-performing technical organization.

The role requires a track record in GMP environments, strong leadership, and the ability to balance safety, asset reliability, and cost with strategic, data-driven decision making.

Qualifications

• Doctorate/Master/Bachelor with required years of engineering leadership experience.
• At least 4 years of people-management or leadership experience.

Responsibilities

• Provide strategic and operational leadership for Engineering, Automation, Maintenance, and Instrumentation functions.
• Ensure safe, reliable, and compliant performance of manufacturing equipment and systems.
• Lead site asset-management and lifecycle programs, including preventive and predictive maintenance.
• Oversee regulatory inspections readiness and GMP compliance across the site.
• Develop budgets and manage resources for safety, quality, supply, and reliability.
• Partner with cross-functional teams to implement long-term site operating strategies.

Skills

Leadership

People management

GMP knowledge

Regulatory collaboration

Education

Doctorate Degree

Master's Degree

Bachelor's Degree

Tools

Maximo CMMS

Microsoft Office

Job description

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

HOW MIGHT YOU DEFY IMAGINATION? If you feel like you're part of something bigger, it's because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Be part of Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleX batch facility combines the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations. Not only featuring the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but also integrating sustainability innovations to reduce carbon and waste.

Director, Engineering

Live

What You Will Do

As Director, Engineering at Amgen North Carolina (ANC), you will lead the sites 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. This role requires a proven site-level leader who can build and lead a high-performing technical organization while balancing safety, GMP compliance, asset reliability, supply continuity, cost, and long-term capability.

In This Role, You Will

• 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 Amgens 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.

Win

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dynamic engineering professional we seekis a leader with these qualifications:

Basic Qualifications

• Doctorate Degree and 4 years of Engineering experience

Or

• Masters Degree and 8 years of Engineering experience

Or

• Bachelors Degree and 10 years of Engineering experience

And

• In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred 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 elevate 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.

Thrive

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen Offers a Total Rewards Plan Comprising Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities Including

• 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, or for field sales representatives, a sales-based incentive plan
• 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