Reliability Engineer
Core
Provide technical support to the Production Department on reliability improvement elements for Fill and Finish equipment, managing predictive maintenance systems and analyzing equipment performance.
Role type
Reliability Engineer (Pharmaceutical Manufacturing)
Builds
Production uptime and equipment reliability for Fill and Finish lines, lyophilizers, and ancillary equipment
Domain
Biopharmaceutical manufacturing / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Reliability engineering principles, Root Cause Analysis (RCA), Failure Modes and Effects Analysis (FMEA), Reliability Centered Maintenance (RCM), data analysis, statistical methods, Computerized Maintenance Management Systems (CMMS), GMP compliance knowledge, Lean Six Sigma methodologies, project management
Preferred skills
Fill and Finish operations experience, aseptic processing experience, predictive maintenance technologies (vibration analysis, thermography, oil analysis), data visualization tools, Lean Six Sigma Green Belt certification
Technologies
CMMS, Microsoft Office Suite, data visualization tools
Responsibilities
Lead reliability improvement initiatives for Fill and Finish equipment, develop and implement predictive and preventive maintenance strategies, conduct RCA and FMEA for equipment failures, monitor and analyze key performance metrics (MTBF, MTTR, availability), review and optimize preventive maintenance schedules, provide technical expertise and troubleshooting support for equipment issues, collect and report on reliability metrics and KPIs, ensure compliance with cGMP, FDA, and EMA requirements
Seniority
Mid-level, hands-on IC
