KBI: US - Facilities Engineer III

KBI BiopharmaDurham, NC
Onsite

About The Position

The Facilities Engineering Department is responsible for all aspects of maintaining the site infrastructure in an active reliable state to support cGMP operations. 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. A Facilities Engineer III is responsible for providing technical support for ongoing operations by serving as a system owner for Facilities’ systems, maintaining the site in a compliant state, and ensuring engineering and quality standards are maintained. Facilities Engineering is responsible for the generation and implementation of Change Controls, Corrective Actions Preventive Actions, Deviations, and other quality system records. As a part of project execution, a Facilities Engineer III will support the design, implementation, commissioning, and validation of new systems or the modification of existing systems and serve as a project manager or project engineer for multiple concurrent projects. Project Management activities may include scope definition, scope adherence, stakeholder agreement, budgeting, scheduling, risk management, procurement, and installation support. Facilities Engineering works within cross-functional teams to ensure the success of these projects. A Facilities Engineer III is expected to coordinate the activities of outside contractors and trades.

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.
  • Ability to concisely write reports and to effectively communicate information to executive management, managers, technicians, government agencies and customers.
  • Ability to apply engineering principles and problem-solving skills to everyday challenges.
  • Strong math and analytical skills required.
  • Ability to perform heat load calculations and size utility systems.
  • Ability to apply mathematical operations to such tasks as frequency distribution, variance analysis, and determination of reliability and validity.

Nice To Haves

  • Facilities management experience in a cGMP manufacturing environment (biotech, pharmaceutical or medical device industries).
  • Knowledge of the facility operations typical to the biotechnology/pharmaceutical industry.
  • Knowledge of federal, state, and local building code requirements.

Responsibilities

  • Direct technical and management aspects of multiple projects to ensue on time delivery, project compliance, budget, and required deliverables.
  • Support the Maintenance and Facilities functions for multiple locations including corrective and preventative maintenance and repair of facilities, utilities, and equipment.
  • 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.
  • 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.
  • Other assigned duties.
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