Senior Reliability Engineer - Adma Biomanufacturing Llc

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infec...

Works with Project Engineering 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 old assets.

Participates in the development of design and installation specifications along with commissioning plans. Participates in the development of criteria for and evaluation of equipment and technical maintenance, repair, and operation (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 include 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.

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. To fulfill this responsibility the Reliability Engineer applies:

a. Data analysis techniques that can include:

i. Statistical Process Control, Reliability modeling and prediction, Fault Tree Analysis, Weibull Tree Analysis, Six Sigma Methodology

b. Root-cause, Root-Cause Failure and Failure Mode Effectiveness Analysis (RCA, RCFA, FMEA)

c. Failure Reporting, Analysis and Corrective Action System (FRACAS)

d. Preliminary Hazards Analysis (PHA)

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.

Provides technical support to production, maintenance management and technical personnel.

Applies value analysis to repair/replace, repair/redesign, and make/buy decisions.

Provide process engineering support for required equipment upgrades and or modifications and champion these efforts including writing and directing all change control activities/ deviations as required by our Quality Systems, OSHA etc.

Assist in and or champion investigation of deviations that are facilities/maintenance related etc. and ensure the appropriate corrective actions are taken.

Direct and or assist in the design and execution of assigned capital projects.

Create purchase requisitions, submit for approval and Manage budgets.

Train SMEs in problem solving techniques.

Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval.

 

Education Requirements: 

Bachelor’s degree in Mechanical Engineering or equivalent.   Experience in the pharmaceutical industry preferred.

 

Experience Requirements: 

Five to seven years of reliability engineering/maintenance experience preferably in a cGMP, pharmaceutical/biological manufacturing environment including experience with process equipment (pumps, centrifuges, refrigeration, fluid flow). 

 

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.