Senior Process Equipment and Reliability Engineer l

Job Title – Senior Process Equipment and Reliability Engineer lJob Location – Cranbury NJJob Summary

The Senior Process Equipment & Reliability Engineer is responsible for supporting and advancing equipment reliability, asset lifecycle management, and maintenance optimization within a biopharmaceutical manufacturing facility. This role serves as a technical leader within the engineering organization, providing expertise in equipment performance, troubleshooting, maintenance strategy, and continuous improvement. The Senior Engineer partners closely with Manufacturing, Maintenance, Quality, Validation, and Process Engineering teams to ensure process and utility equipment operates safely, reliably, and in compliance with cGMP requirements.

The position drives asset performance improvements, supports capital projects, and contributes to reliability programs that enhance equipment uptime, product quality, and operational efficiency.

• Provide technical mentorship and guidance to junior engineers, maintenance personnel, and cross-functional teams.
• Lead reliability-focused initiatives and support implementation of site engineering objectives.
• Serve as a subject matter expert (SME) for equipment reliability, maintenance optimization, and asset performance.
• Participate in cross-functional project teams to support manufacturing, capital projects, investigations, and continuous improvement efforts.
• Support engineering management in developing reliability strategies aligned with business and operational objectives.

• Apply reliability engineering tools including FMEA, RCFA, RCM, and predictive maintenance methodologies.
• Lead investigations into equipment failures and recurring issues, implementing effective CAPAs.
• Analyze equipment performance data and develop strategies to improve uptime, reliability, and maintenance effectiveness.
• Establish and monitor KPIs including MTBF, MTTR, PM compliance, and equipment availability.
• Support condition monitoring and predictive maintenance programs.

• Develop and optimize preventive and predictive maintenance strategies.
• Conduct equipment criticality assessments and risk evaluations.
• Support spare parts optimization and critical spare identification.
• Utilize CMMS systems (Maximo, SAP, or equivalent) to manage asset data, maintenance plans, and performance metrics.
• Contribute to equipment lifecycle planning, replacement strategies, and obsolescence management.

• Provide technical support for troubleshooting, maintenance, and optimization of critical process and utility equipment, including:
  • Bioreactors and fermenters
  • Chromatography and filtration systems
  • Single-use technologies
  • Autoclaves and sterilization equipment
  • Clean utilities (WFI, Clean Steam, Purified Water, Compressed Gases)
  • HVAC and environmental control systems
• Support equipment commissioning, qualification, validation, startup, and operational readiness activities.
• Review and provide technical input on equipment modifications, change controls, and engineering projects.

• Bachelor's degree in Mechanical, Chemical, Electrical, Bioprocess, or related Engineering discipline; advanced degree preferred.
• 5+ years of experience in equipment reliability, maintenance, manufacturing, or process engineering within a cGMP-regulated pharmaceutical or biopharmaceutical environment.
• Strong knowledge of reliability engineering principles, maintenance optimization, and asset lifecycle management.
• Experience supporting biologics manufacturing equipment and utility systems.
• Proficiency with CMMS platforms such as Maximo, SAP PM, or equivalent.
• Strong troubleshooting, root cause analysis, and…