- We are seeking a highly skilled and strategic Reliability Engineering Director to lead our reliability engineering efforts within the Vaccine manufacturing environment
- This role is critical to ensuring the continuous, compliant, and efficient operation of manufacturing equipment and systems that support drug production
- Lead and develop the reliability engineering team composed of engineers focused on vaccine manufacturing equipment and systems
- Develop and implement reliability strategies to maximize equipment uptime, reduce unplanned downtime, and extend asset life while ensuring compliance with FDA, EMA, and other regulatory requirements
- Collaborate closely with Quality Assurance, Validation, Manufacturing, Maintenance, and Engineering teams to embed reliability best practices into equipment design, maintenance, qualification, and operation
Facilitate RBAM (reliability based asset management) on key manufacturing assets and utilize/track key reliability metrics such as MTBF (Mean Time Between Failures), MTTR (Mean Time To Repair), and OEE (Overall Equipment Effectiveness) ensuring actions are completed and driving improved performance and risk ranking of assets
- Drive root cause analysis and failure investigations for critical equipment, ensuring corrective and preventive actions (CAPA) are implemented effectively
- Oversee reliability-centered maintenance (RCM) programs and predictive maintenance initiatives using condition monitoring and data analytics
- Ensure all reliability activities comply with Good Manufacturing Practices (GMP) and support audit readiness
- Lead risk assessments related to equipment reliability and support validation activities, including IQ/OQ/PQ protocols
- Manage budgets, resources, and timelines for reliability projects and continuous improvement initiatives
Communicate reliability goals, progress, and outcomes to senior leadership and cross-functional stakeholders
