Senior Maintenance Reliability Engineer
1 week ago
The Senior Maintenance Reliability Engineer is a critical member of our team, responsible for ensuring the optimal performance and reliability of our manufacturing assets. This role involves monitoring equipment performance, identifying and mitigating issues related to system and equipment reliability, and developing maintenance strategies to optimize equipment performance.
Key Responsibilities- Analyze data from our Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas for improvement.
- Assess the risk and reliability of assets associated with manufacturing and support systems, including failure mode analysis, mean time to failure (MTTF), and mean time to repair (MTTR).
- Develop and maintain a Reliability Centered Maintenance (RCM) strategy to optimize maintenance programs within assigned areas.
- Participate in the development and implementation of other continuous improvement initiatives.
- Establish and maintain Key Performance Indicators (KPIs) for the overall health of critical utility and process systems and build tools to exercise and evaluate KPIs.
- Implement measures to baseline maintenance performance and improvement targets as they relate to cost, quality, downtime, etc.
- Provide reliability, technical, and engineering services and guidance to optimize asset life and resolution to equipment design and operations.
- Collaborate with other departments (e.g., Manufacturing, Maintenance, and Validation) to identify and solve problems while ensuring reliability is effectively integrated throughout the site.
- Conduct training and present information to team members or other stakeholders, as needed.
- Bachelor's degree in Mechanical or Electrical Engineering, or another related field.
- 8 years of Engineering and/or Maintenance experience.
- Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, corrective and preventive action (CAPA), document management system).
- Effective communication, both written and oral.
- Advanced problem-solving skills.
- Ability to effectively present complex information to others.
- Ability to provide feedback to others, including leaders.
- Willingness to partner with global colleagues and lead sub-teams.
- Knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and Food & Drug Administration (FDA) regulations.
- Knowledge of RCM and/or Total Productive Maintenance (TPM).
- Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA.
- Knowledge of the operation and interdependencies of typical utility systems in a pharmaceutical plant (e.g., chillers and cooling towers), boilers/plant steam, utility piping & distribution systems, HVAC, electrical distribution systems, and pharmaceutical RODI, Clean Steam (CS), and Water for Injection (WFI) systems).
- Master's degree in Mechanical or Electrical Engineering with 6+ years of Engineering or other relevant technical experience.
- Prior experience working in a cGMP environment or other highly regulated industry.
- Experience implementing KPIs and other reliability metrics.
- Certified Maintenance and Reliability Professional.
- Six Sigma.
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