Reliability Engineer

Reliability Engineer

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart.

Position Summary

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 an optimal state of operation and cGMP compliance. The role requires applying engineering theory, practices, and principles to determine root cause of equipment failures and to perform equipment performance evaluations.

Essential Functions (ES) and Responsibilities

• Works 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 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. Develop 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.
• Professionally and systematically 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 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.
• 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. These problems include capacity, quality, cost, or regulatory compliance issues.
• Applies data analysis 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)

Competencies

• Ability to follow cGMPs and procedures with great attention to detail.
• Ability to read and understand blueprints.
• Ability to understand and interpret government regulations and customer specifications.
• Ability to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures.
• Ability to work in a high‑pressure, deadline‑driven environment.
• Actively provides feedback to operations management and staff regarding staff performance against SOPs, and works to develop and maintain a collaborative and effective working relationship with operations management.
• Advanced knowledge of standard office software (Microsoft Office including Word, Excel, and Microsoft Project).
• Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
• FDA adherence.
• Identifies ways to improve workflow and identify efficiencies while working within constraints of SOPs.
• Knowledge of instruments and electronics would be helpful to assist in the calibration and repair of control devices.
• 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.

Education Requirements

Bachelor’s degree in mechanical engineering or equivalent.

Experience Requirements

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).

Preferred Experience

• Data analysis and reliability modeling experience in a pharmaceutical/biopharmaceutical setting.
• Experience implementing LCAM and asset maintenance planning.
• Knowledge of FDA regulations and compliance protocols.

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Benefits

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

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ADMA Biologics is an Equal Opportunity Employer.