BioSpace
Job Title
Reliability Engineer
Location Boca Raton, FL
Job Description ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. We are seeking a dynamic and innovative Reliability Engineer to provide maintenance reliability and predictive maintenance support to our Manufacturing Facility and develop/establish reliability engineering tools and programs to ensure equipment remains in optimal state of operation and cGMP compliance.
Position Summary The Reliability Engineer will apply engineering theory, practices, and principles to determine root causes of equipment failures and perform equipment performance evaluations.
Essential Functions and Responsibilities
Ensure the reliability and maintainability of new and modified installations, adhering to the Life Cycle Asset Management (LCAM) process.
Participate in development of design and installation specifications, commissioning plans, and evaluation criteria for equipment and technical MRO suppliers.
Develop acceptance tests and inspection criteria; perform final check-out of new installations and conduct factory and site acceptance testing.
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 that includes value‑added preventive maintenance tasks and effective utilization of predictive and other non‑destructive testing methodologies.
Provide input to a Risk Management Plan that anticipates reliability‑related and non‑reliability‑related risks that could adversely impact plant operation.
Work with Production to analyze assets including Asset Utilization, Overall Equipment Effectiveness, remaining useful life, and other parameters that define operating condition, reliability, and cost.
Develop engineering solutions to repetitive failures and other problems that adversely affect plant operations, including capacity, quality, cost, or regulatory compliance issues. This involves:
Data analysis techniques such as Statistical Process Control, Reliability modeling and prediction, Fault Tree Analysis, Weibull Analysis, Six Sigma (6σ) Methodology.
Root‑Cause Failure and Failure Mode Effectiveness Analysis (RCA, RCFA, FMEA).
Failure Reporting, Analysis and Corrective Action System (FRACAS).
Preliminary Hazards Analysis (PHA).
Job Responsibilities & Competencies
Follow cGMP procedures and others with great attention to detail.
Read and understand blueprints.
Understand and interpret government regulations and customer specifications, and recognize the need for appropriate procedural changes.
Work in high‑pressure, deadline‑driven environments and provide feedback to operations management and staff regarding SOP adherence.
Maintain a collaborative and effective working relationship with operations management.
Advanced knowledge of standard office software (Microsoft Office, Excel, Word, Project).
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
Identify workflow improvements and efficiencies while working within SOP constraints.
Knowledge of instruments and electronics is helpful for calibrating and repairing control devices.
Prepare, present spreadsheets, data analysis, and facilitate small and large group presentations.
Possess time‑management skills and balance multiple assignments simultaneously.
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).
Compliance and Quality System Responsibilities As part of our Quality Systems and cGMP initiatives, employees must ensure compliance with all ADMA Quality policies, standards, SOPs, QA records, HR policies, and EH&S procedures. Any delay or failure to comply must be communicated or escalated to appropriate parties (QA, HR, or EH&S).
Benefits
401(k) 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
Company uses E‑Verify to confirm employment eligibility
ADMA Biologics is an Equal Opportunity Employer
Equal Employment Opportunity Statement ADMA Biologics is an Equal Opportunity Employer.
Other ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. For more information on E‑Verify, please visit www.dhs.gov/E-Verify.
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Location Boca Raton, FL
Job Description ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. We are seeking a dynamic and innovative Reliability Engineer to provide maintenance reliability and predictive maintenance support to our Manufacturing Facility and develop/establish reliability engineering tools and programs to ensure equipment remains in optimal state of operation and cGMP compliance.
Position Summary The Reliability Engineer will apply engineering theory, practices, and principles to determine root causes of equipment failures and perform equipment performance evaluations.
Essential Functions and Responsibilities
Ensure the reliability and maintainability of new and modified installations, adhering to the Life Cycle Asset Management (LCAM) process.
Participate in development of design and installation specifications, commissioning plans, and evaluation criteria for equipment and technical MRO suppliers.
Develop acceptance tests and inspection criteria; perform final check-out of new installations and conduct factory and site acceptance testing.
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 that includes value‑added preventive maintenance tasks and effective utilization of predictive and other non‑destructive testing methodologies.
Provide input to a Risk Management Plan that anticipates reliability‑related and non‑reliability‑related risks that could adversely impact plant operation.
Work with Production to analyze assets including Asset Utilization, Overall Equipment Effectiveness, remaining useful life, and other parameters that define operating condition, reliability, and cost.
Develop engineering solutions to repetitive failures and other problems that adversely affect plant operations, including capacity, quality, cost, or regulatory compliance issues. This involves:
Data analysis techniques such as Statistical Process Control, Reliability modeling and prediction, Fault Tree Analysis, Weibull Analysis, Six Sigma (6σ) Methodology.
Root‑Cause Failure and Failure Mode Effectiveness Analysis (RCA, RCFA, FMEA).
Failure Reporting, Analysis and Corrective Action System (FRACAS).
Preliminary Hazards Analysis (PHA).
Job Responsibilities & Competencies
Follow cGMP procedures and others with great attention to detail.
Read and understand blueprints.
Understand and interpret government regulations and customer specifications, and recognize the need for appropriate procedural changes.
Work in high‑pressure, deadline‑driven environments and provide feedback to operations management and staff regarding SOP adherence.
Maintain a collaborative and effective working relationship with operations management.
Advanced knowledge of standard office software (Microsoft Office, Excel, Word, Project).
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
Identify workflow improvements and efficiencies while working within SOP constraints.
Knowledge of instruments and electronics is helpful for calibrating and repairing control devices.
Prepare, present spreadsheets, data analysis, and facilitate small and large group presentations.
Possess time‑management skills and balance multiple assignments simultaneously.
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).
Compliance and Quality System Responsibilities As part of our Quality Systems and cGMP initiatives, employees must ensure compliance with all ADMA Quality policies, standards, SOPs, QA records, HR policies, and EH&S procedures. Any delay or failure to comply must be communicated or escalated to appropriate parties (QA, HR, or EH&S).
Benefits
401(k) 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
Company uses E‑Verify to confirm employment eligibility
ADMA Biologics is an Equal Opportunity Employer
Equal Employment Opportunity Statement ADMA Biologics is an Equal Opportunity Employer.
Other ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. For more information on E‑Verify, please visit www.dhs.gov/E-Verify.
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