Reliability Engineer

Reliability Engineer

Location: Boston, MA

Position Summary

The Reliability Engineer is responsible for improving the reliability, availability, and maintainability of critical facility, utility, laboratory, and manufacturing assets supporting life sciences operations in the Greater Boston area. This role applies reliability engineering principles and maintenance best practices to minimize equipment downtime, optimize asset performance, and enhance operational efficiency across client facilities. The Reliability Engineer partners closely with Facilities Operations, Engineering, Metrology, Commissioning & Qualification (C&Q), Quality Assurance, and business stakeholders to develop sustainable reliability strategies that support GMP operations, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

Risk Management

• Apply Reliability Engineering methodologies to identify, evaluate, and mitigate risks that could impact equipment performance, reliability, and operational continuity.
• Perform equipment reliability assessments, failure mode evaluations, and develop mitigation strategies for critical assets.
• Analyze equipment performance trends to proactively identify opportunities for reliability improvements and downtime reduction.

Reliability Program Development

• Support the development, implementation, expansion, and continuous improvement of the client's Reliability Engineering program.
• Standardize reliability engineering best practices and promote consistency across multiple client sites.
• Assist in establishing reliability standards, procedures, and engineering guidelines.

Maintenance Strategy & Preventive Maintenance

• Develop, review, implement, and optimize preventive and predictive maintenance strategies for facility and manufacturing assets.
• Create and maintain asset maintenance plans using Reliability-Centered Maintenance (RCM) principles, equipment history, OEM recommendations, and field assessments.
• Conduct field walkdowns to validate maintenance effectiveness and identify improvement opportunities that extend asset life.

Asset Lifecycle Management & Criticality Assessment

• Support the complete asset lifecycle from procurement and installation through commissioning, operation, and decommissioning.
• Develop asset criticality assessments using reliability-based methodologies to prioritize maintenance activities and capital planning.
• Provide technical recommendations for equipment replacement, upgrades, and lifecycle optimization.

Root Cause Analysis & Failure Elimination

• Lead and facilitate Root Cause Analysis (RCA) investigations following equipment failures.
• Identify corrective and preventive actions that eliminate recurring failures and improve long-term asset reliability.
• Track implementation and effectiveness of corrective actions.

Reliability Assessments & Failure Mode Analysis

• Perform Failure Modes and Effects Analysis (FMEA), Failure Modes, Effects and Criticality Analysis (FMECA), or similar reliability studies on critical equipment.
• Evaluate equipment risk and recommend maintenance strategies that reduce operational and business risk.
• Support reliability improvement initiatives through data-driven analysis.

Performance Monitoring & KPI Reporting

• Develop, maintain, and analyze Reliability Engineering metrics and Key Performance Indicators (KPIs).
• Monitor equipment performance indicators including downtime, Mean Time Between Failure (MTBF), Mean Time to Repair (MTTR), maintenance compliance, and asset availability.
• Prepare reports and dashboards that support reliability decision-making and continuous improvement initiatives.

Spare Parts & Materials Reliability

• Perform spare parts criticality assessments and inventory risk evaluations.
• Recommend critical spare inventories and optimized stock levels to support equipment reliability while balancing inventory costs.
• Collaborate with maintenance and procurement teams to improve spare parts management strategies.

CMMS & Data-Driven Reliability Improvements

• Maintain asset data integrity within the Computerized Maintenance Management System (CMMS).
• Prepare and submit updates related to equipment assets, maintenance plans, calibration requirements, and spare parts.
• Utilize CMMS data, equipment history, and performance trending to identify reliability improvement opportunities.
• Partner with CMMS administrators to implement system enhancements supporting reliability best practices.

Equipment & Design Improvements

• Identify equipment modifications, design improvements, and engineering solutions that reduce equipment failures and improve operational reliability.
• Support capital projects by providing reliability engineering input during equipment design, installation, commissioning, and startup.
• Evaluate opportunities to improve maintainability, reliability, and lifecycle cost.

Cross-Functional Collaboration

• Lead technical meetings and collaborate with Facilities Operations, Engineering, Metrology, Commissioning & Qualification (C&Q), Quality Assurance, Manufacturing, and end users to support operational readiness and equipment reliability.
• Provide technical guidance on reliability best practices and maintenance optimization.
• Support site investigations, deviations, change controls, and engineering initiatives as required.

Continuous Improvement

• Drive continuous improvement initiatives focused on maintenance effectiveness, equipment reliability, calibration practices, and engineering service delivery.
• Promote the adoption of Good Engineering Practices (GEP), Reliability-Centered Maintenance (RCM), and industry best practices across client sites.
• Foster a culture of proactive maintenance, reliability, and operational excellence through collaboration, training, and knowledge sharing.

Qualifications

Required

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Reliability Engineering, or a related technical discipline.
• 5 years of reliability engineering, maintenance engineering, or asset management experience within the pharmaceutical, biotechnology, life sciences, or other highly regulated manufacturing environment.
• Strong knowledge of reliability engineering methodologies including RCA, FMEA/FMECA, RCM, Weibull analysis, and asset criticality assessments.
• Experience developing preventive and predictive maintenance strategies.
• Experience utilizing CMMS platforms such as Maximo, SAP PM, Infor EAM, or equivalent.
• Strong analytical, problem-solving, organizational, and communication skills.
• Ability to analyze equipment performance data and translate findings into practical reliability improvements.
• Demonstrated ability to collaborate effectively with multidisciplinary engineering, operations, and quality teams.

Preferred

• Certified Reliability Engineer (CRE), Certified Maintenance & Reliability Professional (CMRP), or equivalent professional certification.
• Experience supporting GMP-regulated pharmaceutical or biotechnology facilities.
• Working knowledge of FDA regulations, cGMPs, Good Engineering Practices (GEP), and Commissioning & Qualification (C&Q).
• Experience supporting clean utilities, HVAC, laboratories, manufacturing process equipment, and facility infrastructure.
• Familiarity with predictive maintenance technologies and reliability analytics.

Core Competencies

• Reliability Engineering
• Reliability-Centered Maintenance (RCM)
• Root Cause Analysis (RCA)
• Failure Modes and Effects Analysis (FMEA/FMECA)
• Asset Lifecycle Management
• Preventive & Predictive Maintenance
• Asset Criticality Assessment
• CMMS Administration
• Risk Assessment & Mitigation
• KPI Development & Data Analytics
• Continuous Improvement (Lean/Six Sigma principles preferred)
• Cross-Functional Collaboration
• Good Engineering Practices (GEP)
• Technical Leadership & Problem Solving