Responsibilities
The GxP Reliability Engineer will provide reliability engineering support for all facilities, utilities systems and equipment including analytical instrumentation, R&D lab support equipment and systems.
This role will facilitate the deployment of 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 collaborate with stakeholders from Maintenance, Metrology, Engineering, Commissioning & Qualification, End users and Quality Assurance to complete deliverables in compliance with the established, procedurally driven programs including, but not limited to, calibration assessments, component criticality assessments, work package creation and modification, and spare parts through change request submission in the validated Computerized Maintenance Management System (CMMS).
This individual will apply cGMP’s and Good Engineering Practices to Maintenance and Reliability program elements to minimize equipment downtime and appropriately support the needs of our stakeholders
Inventory and Spare Parts support for GxP sites Maintain team program trackers and department metrics KPIs Identify and implement maintenance, calibration and spare parts improvements in the CMMS based on equipment trending and feedback to reliability
Perform spare parts risk assessments to determine recommended stock levels to minimize the likelihood of unplanned part related downtime Execute calibration interval determination assessment forms for instruments
Prepare and submit change requests for asset, maintenance, calibration and spare parts updates in the CMMS for asset on boarding
Track completion of CMMS change requests and activation of CMMS attributes by system
Qualifications
Bachelor’s Degree in engineering or Facility Management or Equivalent experience Minimum of 2-10 years of experience in an engineering, facilities, equipment support role in a regulated environment Strong problem solving, technical, math and science skills
Candidates must possess an aptitude for mechanical and electrical systems. How they operate, how they fail, ways to extend equipment reliability and usable life.
Solid understanding of the application of Good Engineering Practices and Maintenance Best Practices and Reliability Engineering to a Facility Maintenance Program Foster change and innovation
Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI Experience with CMMS