Reliability Engineer

About the role

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 remain in optimal state of operation and cGMP compliance. Must have the ability to apply engineering theory, practices, and principles to determine root cause of equipment failures and to perform equipment performance evaluations.

Responsibilities

• Works to ensure the reliability and maintainability of new and modified installations.
• Responsible for adhering to the Life Cycle Asset Management (LCAM) process throughout the entire life cycle of new and existing assets.
• Participate in the development of design and installation specifications along with commissioning plans.
• Participate 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, including factory and site acceptance testing that will assure adherence to functional specifications.
• Guides efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
• Defines, designs, develops, monitors, and refines an Asset Maintenance Plan that includes value-added preventive maintenance tasks and effective utilization of predictive and other non-destructive testing methodologies.
• Provides input to a Risk Management Plan that will anticipate reliability-related and non-reliability-related risks that could adversely impact plant operation.
• 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.
• Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations using techniques such as:
  • Statistical Process Control, Reliability modeling and prediction, Fault Tree Analysis, Weibull Analysis, Six Sigma (6σ) 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)
• Actively provides feedback to operations management and staff regarding staff performance against SOPs.
• Works to develop and maintain a collaborative and effective working relationship with operations management.
• Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs.
• Must be able to prepare, deliver spreadsheets, data analysis, presentations, and facilitate for small and large groups.
• Possess time management skills and be able to balance multiple job assignments at once.
• Adheres to FDA regulations and company policies governing activities, including completion of required compliance training and accurate documentation.

Requirements

• Ability to follow cGMPs and procedures with great attention to detail.
• Ability to read and understand blueprints.
• Understanding and interpretation of government regulations and customer specifications.
• Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures.
• Able to work in a high-pressure, deadline-driven environment.
• Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project).
• Knowledge of instruments and electronics would be helpful to assist in the calibration and repair of control devices.

Qualifications

• Bachelor’s degree in mechanical engineering or equivalent.
• Minimum of 5 years of reliability engineering/maintenance experience in a cGMP, Pharmaceutical/Biological manufacturing environment.
• Experience with process equipment (e.g., pumps, centrifuges, refrigeration, fluid flow).

Benefits

• 401K plan with employer match and immediate vesting.
• Medical, Vision, Life, and Dental Insurance.
• Pet Insurance.
• Company paid Short-Term Disability (STD) and Long-Term Disability (LTD).
• Company Paid Holidays.
• 3 Weeks’ Paid Time Off (within the first year).
• Tuition Assistance (after the first year).
• Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station.