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Reliability Engineer

4 weeks ago

Summit, New Jersey, United States Omni Inclusive Full time
Job Summary:

The Facility and Reliability Engineer plays a crucial role in developing and implementing a Reliability Centered Maintenance (RCM) strategy to support Summit West Cell Therapy Operations. This position is responsible for maintaining a qualified and compliant facility operation status, ensuring the successful operation of facility, laboratory, and business functions at multi-use GMP sites.

The ideal candidate will have strong analytical skills, the ability to identify issues or unmet needs, and initiate projects or programs to address them. This individual will work collaboratively to complete assignments and oversee the successful completion of tasks.

Key Responsibilities:
  • Provides technical expertise, troubleshooting, and improved equipment maintenance/reliability strategies to optimize safe, compliant, and efficient operations of all facility and utility equipment and instrumentation.
  • Prepares asset files, including equipment data sheets, impact assessments, P&ID & drawings, factory O&Ms, factory maintenance recommendations, maintenance work plans, and procedures.
  • Assists in the development and management of a facility document management program to track facility drawings and project turnover packages.
  • Leads on facility workstream to support large-scale project asset and maintenance plan management, identifying and managing contract support to execute according to project schedule.
  • Manages logbook strategies for facility equipment owned and maintained by GMP Facilities.
  • Establishes effective preventative and predictive maintenance plans for GMP Pharmaceutical facility & process utility equipment according to OEM recommendations, industry standards, and process application.
  • Generates SOPs and Work Practices within Client's Document Management System and electronic work plan template and measurement data templates to establish the Use, Maintenance, and Calibration plans for GMP equipment.
  • Works with vendors to define vendor requirements to support maintenance or calibration plans and contracts.
  • Initiates deviations for maintenance work orders that are out of compliance.
  • Manages any CAPAs associated with the CMMS, including PMs or Calibrations performed late or out of conformance.
Requirements:
  • 3+ years of experience in reliability engineering or a related field.
  • Strong understanding of building systems, including life-safety, lighting, mechanical, electrical, plumbing, and HVAC.
  • Knowledge of critical utility systems, such as compressed gas, vacuum, waste.
  • Experience with Computerized Maintenance Management Systems (CMMS).
  • Knowledge of FDA / EU / PDMA / IGJ, GxP environments, ISO, and associated compliance regulations.
  • Proficient in Microsoft Office Suite, including Word, PowerPoint, MS Project, Excel, Outlook, and Visio.
Preferred Qualifications:
  • Bachelor's degree in mechanical or industrial engineering.
  • 3+ years of experience in GxP environments.
  • Lean six sigma knowledge.