Description:

We are seeking a highly motivated Reliability Engineer to support the Facilities and Engineering team in our new Commercial operation facility in Frederick, Maryland. This position is to identify and manage asset reliability risks that could adversely affect plant or business operations for production of cell-based therapeutics.

 

Responsibilities include, but are not limited to:

 

  • Development and maintenance of Reliability Engineering program level guidance documents and implementation of these programs.
  • Develops engineering solutions to repetitive failures such as capacity, quality, cost, or regulatory compliance issues. Familiarity with use of tools such as:
    • Statistical process control
    • Reliability modeling and prediction
    • Weibull analysis
    • Six Sigma (6o) methodology
    • Root Cause Analysis (RCA) or Root Cause Failure Analysis (RCFA)
    • Failure reporting, analysis, and corrective action system (FRACAS)
  • Provides advanced engineering support to ongoing activities and projects acting as a specialist advisor across the Reliability Engineering function.
  • Leads cross-discipline projects focused on Reliability Engineering.
  • Expanded areas of responsibility encompass loss elimination, risk management, and life cycle asset management.
  • Loss Prevention:
    • Tracking production losses and abnormally high maintenance cost assets and find ways to reduce those losses or high costs.
    • Developing plans to eliminate or reduce the losses through root cause analysis and facilitates the implementation.
    • Provides technical support to production, maintenance management and technical personnel.
    • Applies value analysis to repair/replace, repair/redesign and make/buy decisions
  • Risk Management – proficient understanding and use of the following:
    • PHA - Preliminary hazards analysis
    • FMEA - Failure modes and effects analysis
    • CA - Criticality analysis
    • SFMEA - Simplified failure modes and effects analysis
    • MI - Maintainability information
    • FTA - Fault tree analysis
    • ETA - Event tree analysis
    • Life Cycle Asset Management:
    • Provide oversight in equipment selection processes for Capital and OPEX equipment purchases.
    • Development and maintenance of Life Cycle Asset Management (LCAM)
    • Determines asset remaining useful life (RUL) and provides long range capital planning for budgeting.
    • 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 MRO suppliers and technical maintenance service providers.
    • Participates in the final check-out of new installations including factory and site acceptance testing.
  • Execute against the strategic and tactical objectives provided by senior leaders within Engineering and Maintenance, as well as outside of the function.
  • Participates in preparation and review of Maintenance policies, procedures, and performance health indicators.
  • Expands knowledge of engineering concepts that support the Engineering and Maintenance departments and capital projects
  • Professionally and systematically defines, designs, develops, monitors, and refines an asset maintenance plan that includes:
    • Value-added preventive maintenance tasks
    • Effective utilization of predictive and other non-destructive testing methodologies.
  • May manage the day-to-day activities of a team of personnel and/or contractors.
  • May be required to work off hours as it relates to projects or plant emergencies

 

 

Basic Qualifications:

  • Master’s Degree and 3+ years of relevant experience OR
  • Bachelor’s Degree and 5+ years of relevant experience OR
  • High School Degree and 9+ years of relevant experience

 

Preferred Qualifications

  • Excellent communication skills
  • Advanced project management skills
  • Demonstrated ability to develop solutions to a range of moderately complex problems
  • Knowledge and experience of using and designing business systems to manage projects
  • CMMS
  • Smartsheet
  • SharePoint
  • CRL, CMRP and CMRT certifications preferred
  • Previous experience in biotech or pharmaceuticals industry
  • Previous experience working in highly regulated manufacturing environments
  • Previous experience with predictive maintenance technologies and asset performance platforms (Ex. Plantweb Optics)

To discover more about Kite please visit our Career Site at https://www.kitepharma.com/careers/careers-at-kite

 

About Gilead / Kite:

At Gilead, we’re committed to creating a healthier world for everyone – no matter the challenges ahead of us. For more than 30 years, we’ve pursued the impossible, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Through bold and transformative science, we’re driving innovation that has the potential to become the next generation of life-changing medicines. Our ambition is evident in our mission. Because the impossible is not impossible. It’s what’s next. At Kite, we are focused on the cure. Our singular focus is on cell therapy — the use of genetically modified immune cells programmed to target tumors — which we believe has the potential to change the way cancer is treated. Through our focused efforts and important industry and academic partnerships, we have been able to advance our industry-leading pipeline of chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates with the goal of treating both hematological cancers and solid tumors.

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