Sr. Engineer - Reliability System Owner (Drug Substance Ops) Job at Amgen (Juncos)

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. 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.

Job Responsibility

Own the reliability, performance, and lifecycle of critical systems and equipment
Act as System Owner for assigned equipment and systems, maintaining full technical accountability for performance, reliability, and validated state
Investigate unexpected system and equipment failures, performing root cause analysis and leading the development and execution of corrective and preventive actions
Define, own, and continuously optimize equipment reliability strategies, including maintenance strategy, risk mitigation, and lifecycle management
Develop, implement, and improve Preventive Maintenance (PM) strategies and job plans, optimizing maintenance frequencies based on data, failure modes, and reliability analysis
Lead efforts to optimize maintenance intervals through data driven optimization while ensuring equipment reliability, compliance, and validation integrity
Ensure availability and management of spare parts, including identification of critical spares, inventory monitoring (stock / non‑stock), and coordination with technical and 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
Manage and coordinate vendor services, repairs, and technical support for assigned systems
Lead and support equipment troubleshooting activities, providing technical direction and ensuring timely resolution of complex operational issues
Own and review equipment performance and reliability data, including trending of parameters such as pressure, temperature, vibration, and failure modes
Identify, evaluate, and implement predictive and condition‑based maintenance technologies to proactively monitor system health and improve reliability
Translate complex technical findings and reliability insights into clear, actionable communication for operations, engineering, quality, and management stakeholders.

Requirements

Doctorate degree in Engineering
Or Master's degree in Engineering and 2 years of Engineering and/or Mfg Support experience
Or Bachelor's degree in Engineering and 4 years of Engineering and/or Mfg Support experience
Experience in equipment reliability, lifecycle management, and performance optimization
Knowledge of reliability engineering tools and techniques, including FMEA (Failure Modes and Effects Analysis) and predictive maintenance strategies
Proficiency in structured problem‑solving methodologies, such as DMAIC, and root cause analysis tools including Fishbone diagrams and related techniques
Proficiency in 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).

What we offer

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

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

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