Reliability Engineering Manager
Core
Lead the development and implementation of an Equipment Reliability Program to ensure the reliability and maintainability of systems and equipment supporting CGMP manufacturing of gene therapies and vaccines.
Role type
Senior IC Reliability Engineering Manager
Builds
Operational reliability and maintenance programs for manufacturing suites, fill/finish, and utility equipment.
Domain
Biopharmaceutical manufacturing / Gene Therapy
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, budget management, leadership
Preferred skills
GMP or Bio-Pharma maintenance experience, biopharmaceutical equipment design and qualification knowledge
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; Manage cost-benefit analysis for repair versus replace decisions; Ensure compliance with Safety, Quality, and cGMP requirements.
Seniority
Senior, hands-on IC with leadership responsibilities