KBI Biopharma

KBI Biopharma

KBI: US - Facilities Engineer III

USA - NC - Durham - National Way · Mid

Sponsorship not specifiedDetected 73 days ago
Project ManagementBudgetingExcelProcurementCustomer SupportAutoCADElectrical EngineeringGMPFDA RegulatoryMedical DevicesProblem SolvingMicrosoft OfficeVariance AnalysisHSE

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About the role

  • Facilities Engineering oversees the architectural features of the buildings, Structural/Civil, Biotech process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, and Automation for the facility.
  • Facilities Engineering is responsible for the generation and implementation of Change Controls, Corrective Actions Preventive Actions, Deviations, and other quality system records.
  • Facilities Engineering works within cross-functional teams to ensure the success of these projects.

Responsibilities

  • Support Validation with the planning and execution of commissioning and validation protocols.
  • Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems.
  • Develop and maintain standard operating procedures and other procedures for installed systems.
  • The Facilities Engineering Department is responsible for all aspects of maintaining the site infrastructure in an active reliable state to support cGMP operations.
  • Project Management activities may include scope definition, scope adherence, stakeholder agreement, budgeting, scheduling, risk management, procurement, and installation support.
  • Support and comply with engineering standards, drawing controls, project controls and other procedures and standards necessary for the successful operation of the department as well as the creation and maintenance of the same.
  • Knowledge of federal, state, and local building code requirements.
  • Supports the Patriot Park Facility located at 47 National Way in Durham North Carolina 3.

Requirements

  • Bachelor of Science degree in mechanical, chemical, or electrical engineering and 5-6 years of progressively responsible facilities development, facilities construction, and maintenance activities.
  • OR Master of Science degree in mechanical, chemical, or electrical engineering and 2-3 years of progressively responsible facilities development, facilities construction, and maintenance activities.
  • Knowledge of the facility operations typical to the biotechnology/pharmaceutical industry.
  • Reasoning Ability to apply engineering principles and problem-solving skills to everyday challenges.
  • Strong math and analytical skills required.
  • Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.
  • Responsibility Direct technical and management aspects of multiple projects to ensue on time delivery, project compliance, budget, and required deliverables.
  • Execution of assigned tasks will require the ability to access hard to reach areas of the facility to include confined spaces, cramped or low ceilings, interstitials, and mechanical rooms.
  • Non-routine off-hours weekday work may be required.

Skills

  • Incumbents may work with toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment.
  • Carrying of tools and other equipment needed for work in the plant.

Benefits

  • Facilities management experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries).

Company info

  • Language Ability To concisely write reports and to effectively communicate information to executive management, managers, technicians, government agencies and customers.
  • I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.
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This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.