KBI: US - Facilities Engineer III

About the Role

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 architectural features, structural/civil systems, biotech process and laboratory equipment, HVAC, plant and clean utility systems, electrical power and lighting, and facility automation. A Facilities Engineer III provides technical support for ongoing operations by serving as a system owner for Facilities’ systems, maintaining site compliance, and ensuring engineering and quality standards are upheld.

Facilities Engineering is responsible for generating and implementing Change Controls, Corrective Actions Preventive Actions (CAPA), Deviations, and other quality system records. The role involves supporting the design, implementation, commissioning, and validation of new or modified systems, and serving as a project manager or engineer for multiple concurrent projects. Project management activities include scope definition, budgeting, scheduling, risk management, procurement, and installation support. The role requires coordination with cross-functional teams and outside contractors.

Responsibilities

• Direct technical and management aspects of multiple projects to ensure on-time delivery, compliance, budget adherence, and required deliverables.
• Support Maintenance and Facilities functions for multiple locations, including corrective and preventive maintenance and repair of facilities, utilities, and equipment.
• Support Validation with 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 documentation for installed systems.
• Comply with engineering standards, drawing controls, project controls, and other procedures necessary for departmental operations.
• Perform other assigned duties.

Requirements

• Bachelor of Science degree in mechanical, chemical, or electrical engineering and 5-6 years of progressively responsible experience in facilities development, construction, and maintenance.
• OR Master of Science degree in mechanical, chemical, or electrical engineering and 2-3 years of progressively responsible experience in facilities development, construction, and maintenance.
• Preferred: Facilities management experience in a cGMP manufacturing environment (biotech, pharmaceutical, or medical device industries).
• Knowledge of facility operations typical to the biotechnology/pharmaceutical industry.
• Knowledge of federal, state, and local building code requirements.

Skills

• Ability to concisely write reports and effectively communicate with executive management, technicians, government agencies, and customers.
• Strong problem-solving skills and ability to apply engineering principles to everyday challenges.
• Strong math and analytical skills, including heat load calculations, utility system sizing, frequency distribution, and variance analysis.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project), AutoCAD.
• Experience using standard hand tools, power tools, electrical multimeters, large format plotters, and office equipment.

Working Conditions

• Work may involve toxic materials, toxic gases, electrical hazards, and dangerous tools/equipment.
• Primary location: Patriot Park Facility, 47 National Way, Durham, North Carolina.
• Non-routine off-hours weekday work may be required, with a 1-hour maximum response time to system anomalies.
• Non-routine weekend work may be required.
• Must comply with all applicable company, industry (e.g., FDA cGMP, GDP), and regulatory (e.g., Health, Safety, Environment) rules.

Physical Demands

• Strength:
  • Standing: 15% of time (interfacing with staff and servicing equipment).
  • Walking: 15% of time (traveling to various site locations).
  • Sitting: 70% of time (computer work, phone use, meetings).
  • Lifting: Up to 40 lbs (movement of equipment for field installation).
  • Carrying: Up to 20 lbs (tools and equipment for plant work).
• Climbing: Use of ladders for overhead work or accessing mechanical equipment in plant interstitials.
• Movement in confined spaces:
  • Stooping, kneeling, crouching, or crawling in tight or cramped locations around mechanical equipment or plant interstitials.
• Reaching: Overhead work.
• Other: Speaking, hearing, seeing, depth perception, and color vision.