Senior Director Engineering – AML14 Drug Product

Amgen; Juncos (PR); Presencial; USD 250.000 - 360.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits package

Discretionary annual bonus

Stock-based long-term incentives

Time-off plans

Flexible work models

Descripción de la vacante

Amgen seeks a Senior Director of Engineering for its Drug Product FF&I operations in Juncos, Puerto Rico. Lead an integrated engineering organization of about 150 people, drive reliability, capacity, and technology modernization, and partner with cross-functional teams to ensure safe, compliant manufacturing of therapies that help patients.

The role emphasizes strategic leadership, advanced analytics, and AI-enabled improvements within a complex, regulated environment, reporting into the

Formación

• PhD in Engineering or MS/BS with extensive engineering/manufacturing experience.
• At least 5 years of people management/leadership experience.
• Experience in highly regulated pharma manufacturing (cGMP) is preferred.

Responsabilidades

• Lead FF&I Engineering organization strategy across Maintenance & Reliability, Equipment, Utilities, Automation, and Inspection.
• Oversee ~150 engineers and technicians; drive reliability, capacity recovery, and asset modernization.
• Advance digital, AI, and predictive technologies to improve performance and reduce risk.
• Ensure compliance, safety, quality, and regulatory readiness in all engineering activities.

Conocimientos

Leadership

People management

Engineering leadership

cGMP

Data analytics

Educación

PhD in Engineering

MS in Engineering

Bachelor's in Engineering

Descripción del empleo

Career Category Engineering Job Description 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.

Senior Director Engineering – AML14 Drug Product

What you will do

Let’s change the world. In this highly influential leadership role, you will lead the Engineering organization supporting Amgen’s Formulation, Filling & Inspection (FF&I) businesses in Juncos, Puerto Rico, providing the technical leadership required to deliver reliable supply today while building the capabilities needed for the future. You will lead an integrated Engineering organization spanning Maintenance & Reliability Engineering, Equipment Engineering, Utilities, Automation, and Inspection Engineering. With oversight of an approximately 150-person organization, you will shape the strategy, talent, assets, technologies, and operating model behind some of Amgen’s most critical Drug Product manufacturing operations. This role goes beyond sustaining equipment and facilities. You will have the opportunity to transform how Engineering creates business value—strengthening reliability, recovering manufacturing capacity, modernizing critical assets, enabling new products and technologies, and advancing the responsible use of AI, predictive analytics, and digital capabilities to anticipate and prevent failures. You will bring technical credibility to challenge complex engineering decisions, the operational judgment to protect commercial supply, and the leadership capability to transform a large organization. You are equally comfortable developing engineering talent, navigating a manufacturing constraint, evaluating an asset or technology investment, engaging senior stakeholders, and using data to challenge how work gets done. This role will connect deep technical expertise, operational execution, people leadership, and business strategy to ensure our manufacturing operations remain safe, compliant, reliable, competitive, and ready to serve patients.

Specific responsibilities include but are not limited to:

• 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 elevate 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

The Senior Director Engineering we seek is an accomplished technical and people leader who can operate at the intersection of engineering, manufacturing, reliability, technology, and business strategy with the following qualifications:

Basic qualifications:

• Doctorate degree in Engineering and 5 years of engineering or manufacturing support experience OR Master’s degree in Engineering and 9 years of engineering or manufacturing support experience OR Bachelor’s degree in Engineering and 11 years of engineering or manufacturing support experience

In addition to meeting one of the requirements above, you must have 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.

Preferred qualifications:

• 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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer.

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements.

Please contact us to request accommodation.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen