Reliability Engineer, Senior

About AGC Biologics  
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  

JOB SUMMARY

The Reliability Engineer will be a highly qualified SME on manufacturing reliability. This individual will be a critical member of our engineering team responsible for the following disciplines (Process, Electrical, Automation, Mechanical, HVAC, etc.) to support the project.  In addition, we are in the process of creating the optimal EOS structure to support this growth and manage new technical challenges that arise in the future. The Reliability Engineer is a key member of the EOS team and will be responsible for developing and implementing the strategic approach to maintenance and reliability for all site assets.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Lead cross-site working teams to monitor and implement current industry best practices specific to reliability-centered maintenance (RCM) and reporting.
• Working with EOS management, identify and implement Key Performance Indicators (KPI) and metrics, which drive maintenance efficiency and asset utilization opportunities.
• Establish collaborative working relationships with each site/campus, as well as other internal and external functions to identify processes for improvement, oversee and track quality systems, and lead participation in industry benchmarking activities.
• Work directly with the planning and spare parts teams to integrate robust maintenance planning and spare parts kitting to optimize maintenance technician utilization.
• Implement an Asset Reliability strategy that will maximize the Uptime of the assets, develop robust preventative maintenance plans, optimize spare parts inventory, embed predictive maintenance practices, and reduce the risk of having unplanned failure. The three main indicators measuring the effectiveness of the reliability implementation plan include: adequate maintenance job plans, asset downtime reduction & increase uptime, and reduction on deviations generated due assets unplanned failure.
• Periodically update all maintenance job plans to address and avoid equipment failure using historical data, while meeting all of the quality standards set forth by the company and government regulations.

LEADERSHIP SKILLS

• Adaptable; must be willing to remain flexible to accommodate changing business conditions, work requirements and scheduling needs in a rapidly changing environment.
• Must be comfortable working in a fast paced environment and available to provide on-call support when needed.
• Excellent organizational skills with ability to multi-task and prioritize.
• Excellent verbal and written communication skills; ability to communicate with multi-level audiences.

QUALIFICATIONS

Required:

• BS/MS in Engineering (Mechanical, Electrical, or Chemical)
• Minimum of seven (8) years of relevant industry experience in Operational Engineering roles, supporting operations, improving performance.
• Five (5) years’ experience in pharmaceutical or other GMP-regulated industry.
• Minimum of three (3) years troubleshooting process automated systems in Biotech/Pharma Process.
• Experience working or implementing RCM, TPM programs.
• Experience performing risk and criticality assessments for process equipment and implement CBM (Condition-based monitoring) program via Vibration, ultrasonic, infra-red and oil testing regimes.
• Experience managing a project team.
• Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
• Demonstrated ability to develop and maintain clear and accurate documentation of pr