Equipment Reliability Specialist
1 week ago
FPC of Atlanta is a prominent player in the biotechnology sector, dedicated to enhancing and saving lives through innovative therapies. We are at the forefront of providing a comprehensive range of quality plasma-derived and recombinant treatments. Our mission is to discover, develop, and deliver groundbreaking therapies for individuals facing challenges in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas. We leverage advanced scientific platforms, including plasma fractionation, recombinant protein technology, and cell and gene therapy, to drive continuous innovation and address unmet medical needs.
Position Overview:
The Reliability Engineer plays a crucial role in ensuring the reliability and maintenance strategy of utility and manufacturing equipment. This is achieved through ongoing monitoring of equipment performance and implementing necessary improvements using Reliability-Centered Maintenance principles.
Key Responsibilities:
- Act as the technical lead to enhance equipment performance within the facility.
- Develop, implement, and sustain maintenance strategies and plans for plant equipment.
- Continuously improve maintenance procedures, including Preventive Maintenance (PM) schedules, Bill of Materials (BOM), and Spare Parts management to ensure compliance with relevant regulations.
- Recommend and execute initiatives aimed at enhancing equipment reliability in a dynamic cGMP biotechnology environment.
- Provide engineering support to identify and resolve operational and compliance challenges, ensuring equipment is maintained for optimal reliability and longevity.
- Collaborate with engineering teams to classify equipment, establish SAP location hierarchies, and develop Return-to-Service PM instructions.
Reliability Analysis and Improvement:
- Utilize reliability tools and methodologies such as Failure Modes and Effects Analysis (FMEA) and Root Cause Analysis (RCA).
- Analyze data to recommend enhancements based on Computerized Maintenance Management System (CMMS) insights, FMEA, RCA, and reliability metrics.
- Monitor equipment trends to ensure the effectiveness of the maintenance program.
CMMS Management and Reliability Centered Maintenance:
- Ensure execution of Preventative and Predictive Maintenance Programs and Planning Processes.
- Evaluate and implement new predictive technologies for use by technicians and engineers.
- Effectively apply Predictive Maintenance (PdM) technologies and non-destructive testing to minimize maintenance downtime.
Performance Monitoring:
- Measure and report on reliability performance metrics.
- Demonstrate the success of preventative maintenance initiatives through detailed performance reports and dashboards.
Subject Matter Expertise:
- Serve as a Subject Matter Expert (SME) during internal and regulatory audits.
- Commit to continuous improvement in job knowledge and proficiency related to biopharmaceutical engineering best practices and technologies.
- Adhere to safety program requirements, including health and safety mandates.
- Fulfill additional responsibilities as assigned by senior management.
Qualifications:
- Bachelor's degree in an Engineering discipline.
- Experience with Vibration Analysis, Ultrasound Scanning, Infrared Scanning, Oil Analysis, Eddy Current Testing, and Dynamic/Static Motor Current Testing.
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