Director, Facilities Engineering

KBI Biopharma • Durham, NC

2d

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 manufacturing process and laboratory equipment and systems, HVAC, Plant and Clean Utility Systems, Electrical Power and Lighting, and Automation for cGMP facility. As an essential position, under the supervision of the Vice President of engineering; the Director of facilities, will support day-to-day departmental operations including maintenance and calibration of equipment for Manufacturing, laboratories, facilities building, and Utilities for KBI BioPharma’s Sites at Hamlin Road and Venture Center, located in Durham, NC. This position will support activities for Capital Projects, Quality Compliance, environmental health, and safety programs, staffing requirements, regulatory inspections, and department operations by coordinating with internal teams and third-party vendors to meet Quality compliance and safety requirements of sites. Job responsibilities include: Manage the Maintenance, Metrology, and Facilities functions for all KBI Biopharma North Carolina Sites. Direct corrective and preventative maintenance and repair of facilities, utilities, and equipment. Support large Capital Expense Projects on the design, construction, start-up, and commissioning of Facilities and Facilities related equipment. Prepare project status reports and keep management, clients, and others informed of facility status and related issues. Establish and maintain contracts for external services including, but not limited to, Pest Control, security services Landscaping, and Snow Removal. Direct space planning at all North Carolina sites. Develop plans to meet the company’s space needs to be based on the Mid Term Plan. Support CAPA, Change Control, Deviation, SOP development/revisions, Risk Analysis, Root Cause Analysis, and other Quality Systems. Ensure Facilities Quality Compliance is maintained at, or higher than, the level established by site leadership for on-time closure. Represent the Facility’s activities during FDA, EU, or other regulatory inspections and client audits. Establish a system of metrics to evaluate the effectiveness of Maintenance and metrology activities and provide concise, timely updates to the VP of Engineering. Partner with the company’s Environmental Health and Safety program. Including Site Safety Committees, Biological Safety Committees, timely filing of all state and federal documentation, and other programs as necessary to ensure the safety of company personnel and assets. Establish and maintain sustainability programs at all North Carolina Sites. Responsible for the employment, employee motivation, counseling, discipline, and changes in the status of employees supervised.

Requirements

• Minimum Bachelor’s degree in Mechanical Engineering/Electrical Engineering/Chemical Engineering/Biomechanical Engineering.
• Minimum Ten (10) years of progressive experience as a Facilities Associate Director, Facilities Manager, Facilities Supervisor, Facilities Technician, or related role within the pharmaceutical industry.

Responsibilities

• Manage the Maintenance, Metrology, and Facilities functions for all KBI Biopharma North Carolina Sites.
• Direct corrective and preventative maintenance and repair of facilities, utilities, and equipment.
• Support large Capital Expense Projects on the design, construction, start-up, and commissioning of Facilities and Facilities related equipment.
• Prepare project status reports and keep management, clients, and others informed of facility status and related issues.
• Establish and maintain contracts for external services including, but not limited to, Pest Control, security services Landscaping, and Snow Removal.
• Direct space planning at all North Carolina sites.
• Develop plans to meet the company’s space needs to be based on the Mid Term Plan.
• Support CAPA, Change Control, Deviation, SOP development/revisions, Risk Analysis, Root Cause Analysis, and other Quality Systems.
• Ensure Facilities Quality Compliance is maintained at, or higher than, the level established by site leadership for on-time closure.
• Represent the Facility’s activities during FDA, EU, or other regulatory inspections and client audits.
• Establish a system of metrics to evaluate the effectiveness of Maintenance and metrology activities and provide concise, timely updates to the VP of Engineering.
• Partner with the company’s Environmental Health and Safety program. Including Site Safety Committees, Biological Safety Committees, timely filing of all state and federal documentation, and other programs as necessary to ensure the safety of company personnel and assets.
• Establish and maintain sustainability programs at all North Carolina Sites.
• Responsible for the employment, employee motivation, counseling, discipline, and changes in the status of employees supervised.

What This Job Offers

• Job Type: Full-time
• Career Level: Director