KBI BioPharma
Director, Facilities
KBI BioPharma, Durham, North Carolina, United States, 27703
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 department head of Facilities 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 Site located at Patriot Park in Durham, NC. This position will support activities for Capital Projects, Quality Compliance, Environmental health, and safety programs, site security needs, 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.
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 site 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.
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 Department Head 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.
Minimum Requirements:
Knowledge, Skills, Abilities
1) Minimum Bachelor's degree in Mechanical Engineering/Electrical Engineering/Chemical Engineering/Biomechanical Engineering, or similar engineering/science discipline.
2) Minimum Ten (10) years of progressive experience as a Facilities Associate Director/Director, Facilities Manager, Facilities Supervisor, Facilities Technician, or related role with the pharmaceutical industry.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
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. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
As an essential position, under the supervision of the department head of Facilities 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 Site located at Patriot Park in Durham, NC. This position will support activities for Capital Projects, Quality Compliance, Environmental health, and safety programs, site security needs, 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.
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 site 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.
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 Department Head 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.
Minimum Requirements:
Knowledge, Skills, Abilities
1) Minimum Bachelor's degree in Mechanical Engineering/Electrical Engineering/Chemical Engineering/Biomechanical Engineering, or similar engineering/science discipline.
2) Minimum Ten (10) years of progressive experience as a Facilities Associate Director/Director, Facilities Manager, Facilities Supervisor, Facilities Technician, or related role with the pharmaceutical industry.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
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. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.