Reliability Engineer
Core
Ensures maximum equipment availability and cGMP compliance for pharmaceutical API manufacturing sites through reliability strategies, failure analysis, and asset lifecycle planning.
Role type
Reliability Engineer (Manufacturing)
Builds
Reliable manufacturing and facility equipment systems for pharmaceutical API production
Domain
Pharmaceutical manufacturing / Industrial reliability engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis (RCA), Failure mode and effects analysis (FMEA), Weibull analysis, statistical analysis, maintenance planning, risk mitigation, cGMP compliance, asset lifecycle assessment, data-driven improvement, technical documentation
Preferred skills
CMMS, reliability software, statistical tools, pharmaceutical manufacturing processes, condition-based monitoring
Technologies
RCA, FMEA, Weibull analysis, CMMS, reliability software, statistical tools
Responsibilities
Develop and maintain preventive and predictive maintenance strategies; Perform root cause analysis and failure analysis to reduce downtime; Author and approve reliability documentation and lifecycle assessments; Support investigations, deviations, and CAPAs for equipment failures; Partner with cross-functional teams to align reliability strategies with site objectives; Implement data-driven improvements for equipment performance and availability; Lead continuous improvement initiatives for uptime and cost reduction; Ensure compliance with cGMP guidelines and regulatory requirements; Represent the reliability program during internal and external audits; Assist with risk assessments and facility master planning.
Seniority
Mid-level, hands-on IC
