Senior Reliability Engineer

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.
JOB SUMMARY
The Reliability Engineer, Senior will be a highly qualified subject matter expert (SME) on Pharmaceutical/biopharmaceutical GMP and utility equipment systems' reliability. This individual will be a critical member of our engineering operations services (EOS) team and will be responsible for developing and implementing tactical as well as strategic approaches for all site machinery and methods, ensuring reliability for the engineering systems such as Process, Electrical, Automation, Mechanical, HVAC, etc. to support ongoing operations and new projects-related engineering design and reliability assessment studies.
In addition, we are in the process of creating the optimal EOS structure to support learning and growth and this position will have opportunities to manage new technical challenges that arise in the future.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES

• Lead cross-site and cross-functional 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 maintenance operations planning and spare parts teams to develop robust planning processes, and spare parts kitting options and optimize efficient deployment and utilization of maintenance tools and resources.
• Implement an Asset Reliability strategy that will maximize the availability and uptime of the assets, develop robust preventative maintenance (PM) plans, optimize spare parts inventory, embed predictive maintenance practices, and reduce the risk of having unplanned failures.
• The three main indicators measuring the effectiveness of the reliability implementation plan include adequate maintenance job plans, asset downtime reduction, and reduction of deviations generated due to assets' unplanned failures.
• Review current and historical data to periodically update all maintenance job plans to address and avoid equipment failures while meeting all quality standards set forth by the company's Quality System 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 the ability to multi-task and prioritize.
• Excellent verbal and written communication skills; ability to communicate with multi-level audiences.

QUALIFICATIONS
Required:

• BS in Engineering (Mechanical, Electrical, or Chemical)
• Minimum of Eight (8) years of industry experience in Operational Engineering roles, supporting operations to improving performance, out of which four (4) years' experience in the pharmaceutical, biopharmaceutical, or other USFDA GMP=regulated industry.
• Preferred hands-on troubleshooting process automation systems in Biotech/Pharma Processes.
• Experience working or implementing RCM, and TPM programs.
• Experience performing risk and criticality assessments for process equipment and implementing CBM (Condition-based monitoring) program, capacity debottlenecking, cost savings, and continuous improvement.
• Experience managing a project team.
• Experience writing reports outlining new concepts, testing outcomes, and operational efficiencies.
• Demonstrated ability to develop and maintain clear and accurate documentation of manufacturing process and/or supporting utility equipment.
• attention to detail to provide a tactical and strategic focus on the task at hand or project
• write investigations and standard operating procedures (SOPs).
• Proficiency with all Windows-based programs, knowledgeable with one or more CMMS programs.

Preferred:

• A Master's degree is highly preferable.
• EIT or PE is highly desirable.
• Achieved or working towards achieving RCM and/or CMRP Certification
• CRE Certification desirable.
• Senior-level experience in the biotech industry is preferred.

COMPENSATION
$108,080.00 - $148,610.00
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
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 W ant to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.