KBI Biopharma-posted 3 months ago
Durham, NC
1,001-5,000 employees
Professional, Scientific, and Technical Services

The position involves directing concurrent engineering projects that encompass both technical and project management aspects for capital projects, ensuring their success in meeting respective objectives. The technical aspects include architectural features, structural/civil engineering, biotech process and laboratory equipment and systems, HVAC, plant and clean utility systems, electrical power and lighting, and automation. Project management responsibilities include scope definition, adherence, stakeholder concurrence, budgeting, scheduling, risk management, procurement, and installation support, which involves coordinating the activities of contract engineers and trade contractors during system modifications and additions. Additionally, the role supports maintenance and facilities functions across multiple locations, including corrective and preventative maintenance and repair of facilities, utilities, and equipment, while ensuring compliance with all local, state, federal, and corporate guidelines related to health, safety, and environmental functions. The position also supports validation through the planning and execution of commissioning and validation protocols, as well as CAPA, change control, deviation, risk analysis, root cause analysis, and other quality systems. The incumbent will develop and maintain standard operating procedures and other procedures for installed systems, support and comply with engineering standards, drawing controls, project controls, and other necessary procedures and standards for the successful operation of the department.

  • Direct concurrent engineering projects for capital projects.
  • Manage technical aspects including architectural features, structural/civil engineering, biotech process and laboratory equipment, HVAC, plant and clean utility systems, electrical power and lighting, and automation.
  • Oversee project management aspects such as scope definition, adherence, stakeholder concurrence, budgeting, scheduling, risk management, procurement, and installation support.
  • Support maintenance and facilities functions including corrective and preventative maintenance and repair.
  • Ensure compliance with local, state, federal, and corporate guidelines related to health, safety, and environmental functions.
  • Support validation with planning and execution of commissioning and validation protocols.
  • Assist with CAPA, change control, deviation, risk analysis, root cause analysis, and other quality systems.
  • Develop and maintain standard operating procedures for installed systems.
  • Comply with engineering standards, drawing controls, project controls, and other necessary procedures.
  • Bachelor of Science degree in mechanical, chemical, or electrical engineering with a minimum of 5 years of progressively responsible facilities development, construction, and maintenance activities.
  • Bachelor of Science degree in another engineering discipline with a minimum of 7 years of progressively responsible facilities development, construction, and maintenance activities.
  • Bachelor of Science degree in a closely related technical discipline to engineering with a minimum of 9 years of progressively responsible facilities design/development, construction, and maintenance activities.
  • Facilities management experience in a cGMP manufacturing environment (biotech, pharmaceutical, or medical device industries).
  • Experience working with toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment.
  • EEO/AA employer actively seeking to diversify its workforce.
  • Commitment to providing a safe and healthy workplace.
  • COVID-19 vaccination requirement for employees entering KBI sites.
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