Sr. Engineer - Reliability System Owner (Drug Substance Ops)

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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 ENGINEER(Reliability System Owner)

What you will do

Let’sdo this.Let’schange the world! In this vital role, you will own the reliability, performance, and lifecycle of critical systems and equipment, driving data‑driven improvements, robust maintenance strategies, and sustained operational excellence to support the delivery of high‑quality, life‑changing therapies.

Specific responsibilities include but are not limited to:

• Act as System Owner for assigned equipment and systems,maintainingfull technical accountability for performance, reliability, and validated state.

• Investigate unexpected system and equipment failures, performing root causeanalysisand leading the development and execution of corrective and preventive actions to prevent recurrence.

• Define, own, and continuouslyoptimizeequipment reliability strategies, including maintenancestrategy, risk mitigation, and lifecycle management.

• Develop, implement, and improve Preventive Maintenance (PM) strategies and job plans,optimizingmaintenance frequencies based on data, failure modes, and reliability analysis.

• Lead efforts tooptimizemaintenance intervals throughdata drivenoptimization while ensuring equipment reliability, compliance, andvalidationintegrity.

• Ensure availability and management of spare parts, including identification of critical spares, inventorymonitoring(stock / non‑stock), and coordination withtechnicaland maintenance teams.

• Maintain equipment in a validated state, ensuring data integrity, system compliance, and alignment with cGMP and regulatory expectations.

• Serve as technical owner for equipment improvement and upgrade projects, including reliability enhancements and performance optimization initiatives.

• Support New Equipment Introduction (NEI/NPI) activities, ensuring equipment meets user requirements, specifications, validation needs, and operational readiness.

• Manageand coordinate vendor services, repairs, and technical support for assigned systems.

• Lead and support equipment troubleshooting activities, providing technicaldirectionand ensuringtimelyresolution of complex operational issues.

• Own and review equipment performance and reliability data, includingtrending ofparameters such as pressure, temperature, vibration, and failure modes.

• Identify, evaluate, and implement predictive and condition‑based maintenance technologies to proactivelymonitorsystem health and improve reliability.

• Translate complex technical findings and reliability insights into clear, actionable communication for operations, engineering, quality, andmanagementstakeholders.
  

What we expect of you

We are all different! Yet, we all use our unique contributions to serve patients. The Sr. Engineer professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

Preferred Qualifications:

• Experience in equipment reliability, lifecycle management, and performance optimization.

• Knowledge of reliability engineering toolsand techniques, including FMEA (Failure Modes and Effects Analysis) and predictive maintenance strategies.

• Proficiencyin structured problem‑solving methodologies, such as DMAIC, and root cause analysis tools including Fishbone diagrams and related techniques.

• Proficiencyin statistical analysis, Design of Experiments (DOE), and data‑driven decision‑making.

• Knowledge of Drug Substance Downstream operations and equipment, including chromatography columns, buffer preparation systems, analytical systems, and bioreactors (with strong emphasis on downstream processes).

• Demonstrated ability to lead and collaborate with multi‑functional teams to resolve system‑level technical challenges.

• Skilled in translating complex technical data into clear, actionable insights for diverse stakeholders.

• Excellent technical writing and bilingual communication skills (Spanish and English).

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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.

In addition to the base salary, 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:

• 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 and an annual site shutdown

• Flexible work models, including remote work arrangements, where possible
  

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.