BioSpace
Job Description
Reliability Engineer
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, consider ADMA Biologics. We currently have an exciting opportunity available for a Reliability Engineer.
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. Must have the ability to apply 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. Adheres to the Life Cycle Asset Management (LCAM) process throughout the life cycle of new and existing assets.
Participates in the development of design and installation specifications along with commissioning plans. Develops acceptance tests and inspection criteria for equipment and technical MRO suppliers and providers.
Participates in the final check out of new installations, including factory and site acceptance testing to assure adherence to functional specifications.
Guides efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
Develops and maintains an Asset Maintenance Plan that includes preventive maintenance tasks and the use of predictive and non-destructive testing methodologies to identify reliability problems.
Provides input to a Risk Management Plan to anticipate reliability-related risks that could impact plant operation.
Works with Production to analyze assets using metrics such as Asset Utilization, Overall Equipment Effectiveness, remaining useful life, and other parameters defining operation, reliability, and costs.
Develops engineering solutions to repetitive failures and issues affecting plant operations, applying data analysis techniques including:
Statistical Process Control, Reliability modeling and prediction, Fault Tree Analysis, Weibull Analysis, Six Sigma.
Root-cause analysis (RCA), Failure Mode and Effects Analysis (FMEA), FRACAS, and Preliminary Hazards Analysis (PHA).
Qualifications
Ability to follow cGMPs and procedures with great attention to detail.
Ability to read and understand blueprints and interpret government regulations and customer specifications.
Able to evaluate and interpret regulations and implement changes to procedures as needed.
Ability to work in a high-pressure, deadline-driven environment.
Provide feedback to operations management and staff regarding SOPs; maintain collaborative working relationships with management and staff.
Advanced knowledge of Microsoft Office (Word, Excel, Project).
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
FDA adherence and awareness of quality systems.
Knowledge of instruments and electronics is helpful for calibration and repair of control devices.
Ability to prepare and present data analyses and facilitate for groups of various sizes.
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).
Preferred As part of our Quality Systems and cGMP initiatives, employees must ensure compliance with all ADMA Quality policies, standards, and SOPs in their area. This includes timely completion of QA records/reports, HR policies, and EH&S procedures.
Job Benefits In addition to competitive compensation, we offer a comprehensive benefits package including: 401K with employer match and immediate vesting, medical, vision, life and dental insurance, pet insurance, company-paid STD and LTD, holidays, paid time off, tuition assistance (after first year), and other benefits. ADMA Biologics is an Equal Opportunity Employer.
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ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, consider ADMA Biologics. We currently have an exciting opportunity available for a Reliability Engineer.
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. Must have the ability to apply 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. Adheres to the Life Cycle Asset Management (LCAM) process throughout the life cycle of new and existing assets.
Participates in the development of design and installation specifications along with commissioning plans. Develops acceptance tests and inspection criteria for equipment and technical MRO suppliers and providers.
Participates in the final check out of new installations, including factory and site acceptance testing to assure adherence to functional specifications.
Guides efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls, and safety/security systems.
Develops and maintains an Asset Maintenance Plan that includes preventive maintenance tasks and the use of predictive and non-destructive testing methodologies to identify reliability problems.
Provides input to a Risk Management Plan to anticipate reliability-related risks that could impact plant operation.
Works with Production to analyze assets using metrics such as Asset Utilization, Overall Equipment Effectiveness, remaining useful life, and other parameters defining operation, reliability, and costs.
Develops engineering solutions to repetitive failures and issues affecting plant operations, applying data analysis techniques including:
Statistical Process Control, Reliability modeling and prediction, Fault Tree Analysis, Weibull Analysis, Six Sigma.
Root-cause analysis (RCA), Failure Mode and Effects Analysis (FMEA), FRACAS, and Preliminary Hazards Analysis (PHA).
Qualifications
Ability to follow cGMPs and procedures with great attention to detail.
Ability to read and understand blueprints and interpret government regulations and customer specifications.
Able to evaluate and interpret regulations and implement changes to procedures as needed.
Ability to work in a high-pressure, deadline-driven environment.
Provide feedback to operations management and staff regarding SOPs; maintain collaborative working relationships with management and staff.
Advanced knowledge of Microsoft Office (Word, Excel, Project).
Demonstrated ability to achieve goals, overcome obstacles, and meet deadlines.
FDA adherence and awareness of quality systems.
Knowledge of instruments and electronics is helpful for calibration and repair of control devices.
Ability to prepare and present data analyses and facilitate for groups of various sizes.
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).
Preferred As part of our Quality Systems and cGMP initiatives, employees must ensure compliance with all ADMA Quality policies, standards, and SOPs in their area. This includes timely completion of QA records/reports, HR policies, and EH&S procedures.
Job Benefits In addition to competitive compensation, we offer a comprehensive benefits package including: 401K with employer match and immediate vesting, medical, vision, life and dental insurance, pet insurance, company-paid STD and LTD, holidays, paid time off, tuition assistance (after first year), and other benefits. ADMA Biologics is an Equal Opportunity Employer.
#J-18808-Ljbffr