Reliability Engineer

BioSpace; Boca Raton (FL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental Ins.

On-site parking

Job summary

ADMA Biologics in Boca Raton, FL seeks a Reliability Engineer to ensure asset reliability and regulatory compliance. You will implement maintenance and predictive programs, evaluate equipment performance, and guide lifecycle asset management across the manufacturing facility.

The role requires a BS in mechanical engineering and at least 5 years in a cGMP biopharma setting, with hands-on experience in process equipment and reliability analysis.

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).

Responsibilities

• Ensure reliability and maintainability of new and modified installations.
• Develop and maintain an Asset Maintenance Plan (LCAM).
• Collaborate with Production to analyze assets and determine remaining useful life and costs.
• Develop acceptance tests and inspection criteria for installations.
• Support RCA/RCFA/FMEA, FRACAS and PHA processes.

Skills

Reliability engineering

Data analysis

RCA / RCFA / FMEA

FRACAS

cGMP compliance

Education

Bachelor's degree in mechanical engineering

Job description

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. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Reliability Engineer!

Job Title: 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 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.

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. Develops acceptance tests and inspection criteria. Participates in the final check out of new installations. This includes 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.

• Data analysis techniques that can include: 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 the cGMP’s and procedures with great attention to detail

Ability to read and understand blueprints

Ability to understand and interpret 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 high-pressure, deadline-driven environment

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

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

Experience Requirements

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

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.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensive benefits package including:

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

ADMA 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 \"www.dhs.gov/E-Verify\".

ADMA Biologics is an Equal Opportunity Employer.