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

Amgen • Juncos, PR

7d

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. 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’s do this. Let’s change 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.

Requirements

• Doctorate degree in Engineering
• Master’s degree in Engineering and 2 years of Engineering and/or Mfg Support experience
• Bachelor’s degree in Engineering and 4 years of Engineering and/or Mfg Support experience

Nice To Haves

• 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).

Responsibilities

• 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 to prevent recurrence.
• 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.

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 and an annual site shutdown
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

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