Reliability Engineer

Job Description

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. We currently have an exciting opportunity available for a Reliability Engineer.

• Provide maintenance reliability and predictive maintenance support to the Manufacturing Facility and develop/establish the reliability engineering tools/programs to ensure all equipment remains in optimal state of operation and cGMP compliance.
• Apply engineering theory, practices, and principles to determine root causes of equipment failures and perform equipment performance evaluations.
• Ensure the reliability and maintainability of new and modified installations and adhere to the Life Cycle Asset Management (LCAM) process throughout the life cycle of assets.
• Participate in the development of design and installation specifications, commissioning plans, criteria for equipment and MRO suppliers, and development of acceptance tests and inspection criteria.
• Assist in final checkout of new installations, including factory and site acceptance testing to ensure adherence to functional specifications.
• Guide efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
• Define, design, develop, monitor, and refine an Asset Maintenance Plan with value-added preventive maintenance tasks and effective use of predictive and non-destructive testing methodologies.
• Provide input to a Risk Management Plan to anticipate reliability-related risks that could impact plant operation.
• Work with Production to analyze assets (Asset Utilization, Overall Equipment Effectiveness, remaining useful life, etc.) to define operating condition, reliability, and costs.
• Develop engineering solutions to repetitive failures and problems affecting plant operations (e.g., capacity, quality, cost, regulatory compliance) using data analysis techniques such as:
  • Statistical Process Control
  • Reliability modeling and prediction
  • Fault Tree Analysis
  • Weibull Analysis
  • Six Sigma (6σ) Methodology
• Root-cause, RCFA, FMEA, FRACAS, and PHA methodologies as part of reliability improvement efforts.

• Ability to follow cGMPs and procedures with great attention to detail.
• Ability to read and understand blueprints; interpret government regulations and customer specifications.
• Able to evaluate and interpret regulations and adjust procedures accordingly.
• Ability to work in a high-pressure, deadline-driven environment.
• Provide feedback to operations management and staff regarding SOP compliance and foster collaboration 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 and a mindset to identify workflow improvements within SOP constraints.
• Knowledge of instruments and electronics is helpful for calibration and repair of control devices.
• Ability to prepare and deliver spreadsheets, data analyses, presentations, and facilitate for small and large groups.

• Education: Bachelor’s degree in mechanical engineering or equivalent.
• Experience: 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).

As part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs. This includes ensuring all QA records and reports, HR policies, and EH&S procedures are completed in a timely manner. Any delay or failure to comply should be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.

• 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)
• Easily accessible to Tri-Rail. Free shuttle to the Boca Tri-Rail station
• ADA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees.
• To learn more about E-Verify, including your rights and responsibilities, please visit (Use the "Apply for this Job" box below)..
• ADMA Biologics is an Equal Opportunity Employer.