This individual will provide support for GxP Facility Operations/Engineering department at Vertex GxP sites as part of the Reliability Engineering team.
The ideal candidate will be responsible for ensuring the reliability and performance of our equipment/systems through Reliability best practices and continuous improvement initiatives.
This role will also execute documentation/forms/spreadsheets to roll out Maintenance and Reliability Best Practices for new and existing equipment, facilities, and utilities at GxP sites including asset management, calibration, preventative maintenance, and spare parts.
This resource will work collaboratively with stakeholders from Maintenance, Metrology, Engineering, Commissioning & Qualification, End users, and Quality Assurance to complete asset hierarchy, calibration assessments, criticality assessments, work packages, and spare parts through change request submission in the Computerized Maintenance Management System (CMMS).
This resource will use Good Engineering Practices as well as Maintenance and Reliability Best Practices to support operational readiness and continuous improvements for GxP sites.
Key ResponsibilitiesExecute calibration interval determination assessments for instruments on new systems.Drive continuous improvement of maintenance, calibration, and engineering service delivery, adopting and deploying best practices across the GxP sites.Contribute to the development of an asset life cycle management.Develop asset maintenance plans and required spare parts from Reliability Engineering assessments and field walk downs to prolong the lifespan of equipment.Perform spare parts risk assessments to determine recommended stock levels to minimize the likelihood of unplanned part-related downtime.Prepare and submit change requests for asset, maintenance, calibration, and spare parts updates in the CMMS.Identify and implement asset, maintenance, calibration, and spare parts improvements in the CMMS based on equipment trending, feedback to reliability, and other continuous improvement initiatives.Perform Root Cause Analysis on equipment to prevent future failures and reduce unplanned downtime.Conduct reliability assessments and analyses to identify potential failure modes and develop strategies for mitigation.Track completion of CMMS change requests and activation of CMMS attributes by system for project-related facilities, equipment, and utilities for operational readiness of GxP site(s).Develop and advance Reliability Engineering KPIs to improve equipment reliability and decision making.QualificationsCandidate must possess an aptitude for mechanical and electrical systems, including how they operate, how they fail, and ways to extend equipment reliability and life.Minimum engineering degree, or demonstrated equivalent experience.Solid understanding of the application of Good Engineering Practices and Maintenance Best Practices and Reliability Engineering impact to a Facility Maintenance Program.Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.Excellent communication skills, with the ability to collaborate effectively with cross-functional teams.Experience working with a Computerized Maintenance Management System (CMMS).Experience developing metrics/KPIs to track progress and continuous improvements.GMP experience preferred.
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