Reliability & Lifecycle Engineer

Role Summary

Senior Reliability and Lifecycle Engineer based in Devens, MA. Responsible for developing and improving maintenance and operations practices to enhance reliability, establishing a robust lifecycle strategy for equipment, and leading predictive maintenance initiatives to reduce life-cycle costs.

Responsibilities

• Develop and improve maintenance and operations systems, practices, policies, and procedures to enhance reliability and establish a continuous improvement philosophy.
• Ensure designs and modifications include reliability/availability/maintainability/safety and life cycle costing reviews; participate in design/installation specifications, commissioning and qualification plans.
• Establish equipment criticality ranking and apply appropriate maintenance philosophies to develop a robust system lifecycle strategy.
• Monitor and analyze failures to increase reliability and reduce life-cycle costs; develop KPIs to monitor and optimize lifecycle.
• Drive a CBM/PdM program (laser alignment, thermography, oil analysis, vibration monitoring, ultrasound) and determine equipment to monitor; set alarm levels.
• Drive proactive action at early stages of failures identified by CBM/PdM; lead FMEA and RCM exercises with cross-functional teams.
• Develop the site's asset investment plan (State of Good Repair) to maintain high equipment reliability while controlling costs; identify spare parts requirements and support stock levels.
• Support documentation for maintenance activities (Maximo Job Plans, Data Sheets, Work Instructions) and compliance activities related to Quality Events, CAPA, change management and contamination investigations.
• Perform Root Cause Failure Analysis and coordinate with Planning & Scheduling to oversee job assignments and lead PdM technicians; contribute to departmental budgeting.

Qualifications

• 5+ years (or equivalent) of maintenance and reliability experience in manufacturing equipment.
• Ability to manage and organize complex technical projects; familiarity with the manufacturing operations of large-scale facilities; GMP experience.
• Strong knowledge of preventive, predictive maintenance processes and practices to improve equipment reliability.
• Knowledge of RCM, CMMS (Maximo preferred) and PdM technology software.
• Knowledge of regulatory, environmental, GMP requirements and knowledge of manufacturing facilities, utility and building maintenance operations.
• Expertise with typical biopharmaceutical upstream and downstream processing and support equipment (e.g., scale up and large-scale bioreactors, filtration and ultrafiltration, CIP, SIP, centrifugation, chromatography, autoclaves, and glass washers).
• Effective in both a team environment and as an individual contributor.
• Knowledgeable in engineering principles related to instrumentation in a Biopharmaceutical process troubleshooting.
• Adaptable to a fast-paced, complex, and ever-changing business environment.
• Ability to effectively communicate verbally and in writing with cross-functional groups to achieve timely results.

Education

• B.S. in Engineering (Reliability or Mechanical preferred)

Skills

• Instrumentation troubleshooting in biopharmaceutical processes
• FMEA and Reliability Centered Maintenance (RCM) facilitation
• CMMS and PdM technology familiarity (Maximo preferred)
• Strong project management and cross-functional collaboration