Maintenance Reliability Engineer

Job Title:   Maintenance Reliability Engineer

• Location: Pearl River, NY

About the Job

The Engineering & Maintenance Department at the Pearl River site plays a critical role in supporting the production of Flublok, a key vaccine product manufactured in over 70,000 sq. ft. of GMP-compliant manufacturing, laboratory, and administrative space. As the primary U.S.-based facility for Flublok production, Pearl River is also a Homeland Security-designated and licensed site for the supply of Bird Flu Vaccine drug substance in the event of a pandemic. 

Our team is dedicated to ensuring the reliability, safety, and efficiency of site-wide operations through:

• Expert maintenance, troubleshooting, and continuous improvement of complex and site-specific equipment and systems.

• We operate in a 24/7 GMP production environment, requiring precision, responsiveness, and a commitment to Good Documentation Practices (GDP).

• We manage a monthly spend exceeding $1.5MM, with an annual energy budget of over $1MM, directly impacting the site's profitability and operational continuity.

• Our mission is to enable uninterrupted vaccine production by maintaining high standards of equipment performance, safety, and compliance.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main Responsibilities

• Support GMP manufacturing operations through proactive and reactive maintenance.

• Ensure equipment reliability across critical systems affecting production and lab environments.

• Respond to urgent needs with flexibility, including up to 25% overtime and shift work based on production cycles.

• Foster a proactive safety culture with a goal of zero injuries.

• Maintain Equipment Periodic Maintenance Plans.

• Maintain Spare Parts Inventory.

• Participate in department rotational weekly on-call schedule

The Methods & Reliability Engineer is responsible for defining the overall structure of the maintenance & metrology processes and strategy for methods and reliability engineering and continuous improvement of assets, optimizing the application of preventive and predictive maintenance in order to achieve the right maintenance strategy to support the business without compromising safety or compliance.

The Methods & Reliability Engineer is accountable for the management and execution of the following:

• Preventive Maintenance Development through Failure Modes and Effects Analysis (FMEA)

• Simplified Maintenance Review (SMR)

• Original Equipment Manufacturer (OEM) recommendations or Run to Failure (RTF) and that the assessment is reviewed on a regular basis

• Driving out sources of repetitive assets and process failures from both a mechanical and automated system perspective

• Provide proactive leadership, direction, single point accountability, and technical expertise required to achieve and sustain optimum reliability, and to develop and refine preventive/predictive maintenance programs and be knowledgeable on instrument calibration concepts and methods maintainability, useful life, and life cycle of equipment.

• Develop a preventive maintenance strategy for all equipment using the output from a criticality and complexity assessment to determine the method of preventive maintenance development.

• Working knowledge of automated process controls and/or building management systems, and able to support and troubleshoot such systems to ensure reliable and compliant performance.

• Oversee and manage calibration and metrology programs, develop engineering solutions to chronic reliability problems, provide leadership and troubleshooting expertise/guidance for corrective maintenance activities.

• Provide troubleshooting assistance as well as developing and implementing plans for continuous improvement of production equipment, processes, and process controls, as well as to apply appropriate predictive and preventive maintenance solutions that will assure reliability and function

• Strong foundation in reliability engineering, root cause analysis, and preventive maintenance

• Experience with PowerBI, RPA, and real-time analytics

• Familiarity with IoT, digital twins, and smart manufacturing technologies

• Understanding of AI applications in predictive maintenance and asset man