Senior Director Engineering – AML14 Drug Product

Amgen • Juncos, PR

11d

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• Doctorate degree in Engineering and 5 years of engineering or manufacturing support experience
• Master’s degree in Engineering and 9 years of engineering or manufacturing support experience
• Bachelor’s degree in Engineering and 11 years of engineering or manufacturing support experience
• At least 5 years of people-management and/or leadership experience leading teams, projects, or programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience referenced above.

Nice To Haves

• Significant Engineering, Maintenance, Reliability, Automation, and/or Manufacturing leadership experience within complex, highly regulated manufacturing operations, ideally including aseptic Drug Product filling and inspection.
• Demonstrated success leading large, multidisciplinary technical organizations and developing leaders, technical capability, organizational performance, and succession pipelines.
• Deep understanding of equipment reliability and asset-management strategies, including preventive and predictive maintenance, root-cause analysis, lifecycle management, obsolescence, critical spares, and continuous improvement.
• Experience improving manufacturing performance through OEE, equipment availability, downtime reduction, changeover optimization, capacity recovery, and other measurable operational outcomes.
• 15+ years of progressively complex / strategic cGMP-regulated manufacturing experience, with strong background in filling, formulation, and inspection areas, including support for regulatory inspections and management of technical and quality risks.
• Experience developing and executing engineering strategies, asset roadmaps, capital investments, capacity plans, and technology modernization initiatives while protecting ongoing commercial operations.
• Demonstrated ability to lead complex product introductions, technology transfers, qualification/PPQ activities, capital projects, or manufacturing technology implementations through cross-functional organizations.
• Strong business and financial acumen, including experience managing significant budgets, allocating resources, evaluating competing investments, and connecting engineering priorities to business and supply outcomes.
• Demonstrated ability to use data, advanced analytics, digital technologies, automation, and AI-enabled capabilities to improve engineering decision-making, reliability, productivity, and organizational effectiveness.
• Exceptional leadership, executive communication, influencing, negotiation, and change-management skills, with the ability to make disciplined decisions in ambiguous environments and build strong partnerships across organizational boundaries.
• Ability to create a culture of accountability, safety, quality, transparency, innovation, belonging, and constructive challenge, where teams raise risks early and continuously improve how work is performed.
• Excellent written and verbal communication skills in English; Spanish language proficiency is preferred but not required.

Responsibilities

• Lead the integrated FF&I Engineering organization and strategy. Set the engineering strategy, operating model, asset roadmap, workforce plan, and technical priorities across Maintenance & Reliability, Equipment Engineering, Utilities, Automation, and Inspection Engineering to enable reliable supply, manufacturing performance, future capacity, and the long-term business portfolio.
• Deliver manufacturing performance through engineering and reliability excellence. Own the maintenance and reliability system across process equipment, utilities, automation, instrumentation, and supporting assets. Improve equipment availability, OEE, changeovers, campaign execution, decontamination reliability, and recovery of lost capacity through preventive, predictive, and optimized maintenance strategies.
• Transform reliability from reactive problem-solving to predictive performance. Strengthen the Reliability organization and eliminate repeat failures through rigorous root-cause analysis, sustainable corrective and preventive actions, effectiveness verification, condition monitoring, and early identification of weak signals. Establish outcome-based performance management connecting engineering actions to OEE, downtime, lost hours, recovered units, repeat events, MTBF, maintenance effectiveness, and risks to the manufacturing plan.
• Shape the future of FF&I's assets, technology, and infrastructure. Own lifecycle and obsolescence strategies for critical assets, including replacement planning, critical spares, capacity, technology upgrades, utilities, and business continuity. Partner on capital investments, facility modernization, new filling and inspection technologies, automation upgrades, and technical improvements, ensuring new capabilities are qualified, operationally ready, and introduced without compromising commercial supply.
• Ensure technical readiness, compliance, and risk management. Maintain the highest standards of safety, quality, cGMP compliance, environmental requirements, and inspection readiness. Ensure equipment and technical systems are prepared for product launches, technology transfers, engineering runs, qualification campaigns, PPQs, and commercial implementation while driving timely and sustainable resolution of quality events, technical deviations, and operational risks.
• Build and lead a high-performing Engineering organization. Provide active leadership to an approximately 150-person organization operating through a blended FTE/EW workforce model. Build capability through strategic workforce planning, talent selection, development, coaching, functional rotations, performance management, and succession planning. Develop leaders who make timely decisions, anticipate and escalate risks, execute independently, and remain accountable for business outcomes rather than activity completion.
• Accelerate digital, AI, and operational transformation. Advance simplification, automation, real-time performance visibility, predictive technologies, advanced analytics, Lean practices, and human-error reduction. Build AI literacy across Engineering and establish the responsible use of approved AI capabilities to support predictive-failure modeling, troubleshooting, process-variability trending, planned interventions, and automated analysis—while maintaining appropriate technical judgment, quality processes, and established AI-use guardrails.
• Operate as a strategic business leader and enterprise partner. Manage the applicable Engineering labor budget, together with applicable maintenance, repair, spare-parts, operating-supply, non-capital equipment, and engineering-technology investments. Allocate resources based on supply priorities, risk, asset condition, and business value, while partnering across Manufacturing, Quality, Process Development, Validation, Supply Chain, Digital, enterprise networks, regulatory agencies, suppliers, and external technical partners to solve complex problems and advance the competitiveness of the business.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree