Reliability Engineer

Reliability Engineer

The Reliability Engineer will provide maintenance reliability and predictive maintenance support to the manufacturing facility and develop/establish the reliability engineering tools/programs to ensure that all equipment remains in optimal state of operation and cGMP compliant from a maintenance and engineering perspective. The candidate must have the ability to apply engineering theory, practices and principles to determine the root cause of equipment failures and to perform equipment performance evaluations.

Responsibilities

• Works with Project Engineering to ensure the reliability and maintainability of new and modified installations. The Reliability Engineer is responsible for adhering to the Life Cycle Asset Management (LCAM) process throughout the entire life cycle of new and old assets.
• Participates in the development of design and installation specifications along with commissioning plans. Participates in the development of criteria for and evaluation of equipment and technical MRO suppliers and technical maintenance service providers. Develops acceptance tests and inspection criteria.
• Participates in the final check out of new installations. This includes factory and site acceptance testing that will ensure adherence to functional specifications.
• Guides efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
• Professionally and systematically define, design, develop, monitor and refine an Asset Maintenance Plan that includes value-added preventive maintenance tasks and effective utilization of predictive and other non-destructive testing methodologies designed to identify and isolate inherent reliability problems.
• Provides input to a Risk Management Plan that will anticipate reliability-related, and non-reliability-related risks that could adversely impact plant operation.
• Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations. These problems include capacity, quality, cost or regulatory compliance issues. To fulfill this responsibility the Reliability Engineer applies:
  • Data analysis techniques that can include:
    • Statistical Process Control, Reliability Modeling and Prediction, Fault Tree Analysis, Weibull Tree Analysis, Six Sigma (6s) Methodology
  • Root-Cause, Root-Cause Failure and Failure Mode Effectiveness Analysis (RCA, RCFA, FMEA)
  • Failure Reporting Analysis and Corrective Action System (FRACAS)
  • Preliminary Hazards Analysis (PHA)
• Works with Production to perform analyses of assets including, asset utilization, overall equipment effectiveness, remaining useful life and other parameters that define operating condition, reliability and costs of assets.
• Provides technical support to production, maintenance management and technical personnel.
• Applies value analysis to repair/replace, repair/redesign, and make/buy decisions.
• Provide process engineering support for required equipment upgrades and/or modifications and champion these efforts including writing and directing all change control activities/deviations as required by our Quality Systems, OSHA etc.
• Assist in and/or champion investigation of deviations that are facilities/maintenance related etc. and ensure the appropriate corrective actions are taken.
• Direct and or assist in the design and execution of all capital projects assigned.
• Create purchase requisitions, submit for approval and manage budgets.
• Train SMEs in problem solving techniques.
• Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval.

Qualifications

• Bachelors degree in Mechanical Engineering or equivalent
• Experience in the pharmaceutical industry preferred.
• Five to seven years of reliability engineering/maintenance experience preferably in a cGMP, pharmaceutical/biological manufacturing environment including experience with process equipment (pumps, centrifuges, refrigeration, fluid flow).