AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.
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. In addition, this position is the SME in
critical engineering disciplines (Process, Electrical, Automation, Mechanical, HVAC, etc.)
- Lead cross-site working teams to monitor and implement current industry best practices specific to reliabilitycentered 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.
KNOWLEDGE, SKILLS & ABILITIES:
- Adaptable; must be willing to remain flexible to accommodate changing business conditions, work
requirements and scheduling needs in a rapidly changing environment.
- Demonstrated attention to detail with the ability to focus on the project or task at hand and consistently deliver error free results
- 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.
- Demonstrated proficiency with all Windows based programs, knowledgeable with any CMMS program
- Excellent verbal and written communication skills; ability to communicate with multi-level audiences.
- Demonstrated ability to write investigations and standard operating procedures (SOP’s), 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 process equipment or manufacturing processes.
Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.
- BS in Engineering (Mechanical, Electrical, or Chemical) with a minimum of seven (7) years of relevant industry experience in Operational Engineering roles, supporting operations, improving performance. MS highly desired
- Minimum of Five (5) years’ experience in pharmaceutical or other GMP-regulated industry
- Minimum of three (3) years troubleshooting process automated systems in Biotech/Pharma Process
- EIT or PE highly desirable
- RCM Certification desirable
- CMRP Certification required
- CRE Certification desirable
- Senior level experience in biotech industry (preferred).
- Experience working or implementing RCM, TPM programs.
- Experience performing risk and criticality assessments for process equipment and implement CBM (Conditionbased monitoring) program via Vibration, ultrasonic, infra-red and oil testing regimes
- Experience managing a project team.
- Equivalent education and experience may substitute for stated requirements
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