Reliability Engineering Manager
Core
Lead the development and implementation of an Equipment Reliability Program for CGMP manufacturing facilities to ensure operational reliability and maintainability of systems and equipment.
Role type
Reliability Engineering Manager
Builds
Reliable manufacturing operations for advanced therapeutic products (AAV, viral vectors, vaccines)
Domain
Biopharmaceutical manufacturing / Reliability Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Reliability engineering, Root Cause Analysis, Failure Mode and Effects Analysis, Statistical Process Control, reliability modeling, Fault Tree Analysis, Weibull Analysis, Six Sigma, mechanical and electrical design, preventive and predictive maintenance, condition monitoring, non-destructive testing, budget management, change control compliance
Preferred skills
GMP or Bio-Pharma maintenance experience, biopharmaceutical equipment design and qualification knowledge, bioreactor and chromatography system expertise
Technologies
Statistical Process Control, Fault Tree Analysis, Weibull Analysis, Six Sigma
Responsibilities
Lead the Equipment Reliability Program including preventive and predictive maintenance; Direct engineering solutions for recurring equipment failures; Oversee Root Cause Analysis and Failure Modes and Effects Analysis; Collaborate with Manufacturing and Engineering to evaluate asset performance; Manage cost-benefit analysis for repair versus replace decisions; Ensure compliance with Safety, Quality, and cGMP requirements
Seniority
Manager, hands-on IC with team oversight