What are the responsibilities and job description for the Manager, Facilities position at KBI Biopharma?
Job Summary
The Maintenance Manager is responsible for all aspects of maintaining the site infrastructure in a fit-for-use, reliable state to support cGMP operations in a 24/7 CDMO commercial manufacturing facility. The Manager oversees day-to-day maintenance operations, including planning and scheduling, coordinating work-order execution, troubleshooting and problem-solving, and ensuring the quality and completeness of maintenance documentation for cGMP manufacturing, laboratories, warehouse, and administrative areas.
The Manager leads and directs Maintenance Supervisors and a team of maintenance technicians. The role also manages external vendors, and the associated service contracts, to maintain the site and architectural/facility systems, including HVAC, boilers, chillers, plant and clean utility systems, electrical power and lighting, and automation for the cGMP facility.
As an essential position, the Facility Maintenance Manager supports day-to-day departmental operations, including general maintenance of utilities, equipment, buildings, premises, and grounds at KBI BioPharma’s Hamlin Road site in Durham, NC. This position coordinates with internal teams and manages third-party vendors to ensure compliance and safety requirements are met.
The Manager cultivates a team environment and develops a culture of continuous improvement to ensure a high level of equipment availability for operations. The Manager coaches, mentors, and empowers maintenance staff, and develops training materials for the team. The role works with Engineering to review data analysis of equipment performance, trending, and maintenance metrics and performance indicators to increase equipment performance and reliability.
The Manager ensures alignment and coordination with other functions such as Calibration, Engineering, Manufacturing, Validation, EHS&S, and Quality Assurance, and leads efforts of the maintenance team across functional boundaries.
The Manager also generates and resolves deviations related to the maintenance program; supports internal and external audits; and develops and executes Corrective Action Plans (CAPAs) as required. The individual may represent the functional area to clients, auditors, and inspectors.
Job Responsibilities
Knowledge, Skills, Abilities
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500 customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
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.
The Maintenance Manager is responsible for all aspects of maintaining the site infrastructure in a fit-for-use, reliable state to support cGMP operations in a 24/7 CDMO commercial manufacturing facility. The Manager oversees day-to-day maintenance operations, including planning and scheduling, coordinating work-order execution, troubleshooting and problem-solving, and ensuring the quality and completeness of maintenance documentation for cGMP manufacturing, laboratories, warehouse, and administrative areas.
The Manager leads and directs Maintenance Supervisors and a team of maintenance technicians. The role also manages external vendors, and the associated service contracts, to maintain the site and architectural/facility systems, including HVAC, boilers, chillers, plant and clean utility systems, electrical power and lighting, and automation for the cGMP facility.
As an essential position, the Facility Maintenance Manager supports day-to-day departmental operations, including general maintenance of utilities, equipment, buildings, premises, and grounds at KBI BioPharma’s Hamlin Road site in Durham, NC. This position coordinates with internal teams and manages third-party vendors to ensure compliance and safety requirements are met.
The Manager cultivates a team environment and develops a culture of continuous improvement to ensure a high level of equipment availability for operations. The Manager coaches, mentors, and empowers maintenance staff, and develops training materials for the team. The role works with Engineering to review data analysis of equipment performance, trending, and maintenance metrics and performance indicators to increase equipment performance and reliability.
The Manager ensures alignment and coordination with other functions such as Calibration, Engineering, Manufacturing, Validation, EHS&S, and Quality Assurance, and leads efforts of the maintenance team across functional boundaries.
The Manager also generates and resolves deviations related to the maintenance program; supports internal and external audits; and develops and executes Corrective Action Plans (CAPAs) as required. The individual may represent the functional area to clients, auditors, and inspectors.
Job Responsibilities
- Manage and coordinate day-to-day departmental operational activities, including general maintenance of utilities, equipment, buildings, premises, and grounds to ensure they remain in good repair support the site operations. Promote a safe work environment, practices, and standards at all times.
- Manage internal staff and third-party contractors, performing preventive and corrective maintenance on critical utilities, building systems, and manufacturing equipment. Coordinate with other departments to ensure seamless execution of activities.
- Supports activities related to capital and improvement projects.
- Supports departmental activities related to inventory management and quality systems, including change control, deviations, risk analysis, root cause analysis, CAPA, and other assigned tasks.
- Supports and participates client visits, regulatory audits, and related responses.
- Supports utility alarm notifications, and emergency calls after hours and over weekends as needed to support business requirements.
Knowledge, Skills, Abilities
- High School diploma or equivalent, preferably with hands-on or vocational school training, and a minimum of ten (10) years of experience as a general maintenance mechanic in a manufacturing environment; or an equivalent combination of training and experience, or A.S./A.A. Degree in Mechanical/Utilities/ Information Technology; or Licensed Journeyman.
- Experience in a cGMP pharmaceutical manufacturing or other regulated industry preferred.
- Minimum five (5) years of management experience preferred.
- Ability to read and comprehend instructions, correspondence, and memos. Ability to write routine correspondence. Ability to respond to common inquiries or complaints from employees and/or clients. Ability to respond effectively to the most sensitive inquiries or complaints.
- Ability to apply common sense understanding to carry out instructions furnished in written or oral form. Ability to interpret a variety of instructions furnished in written or oral form.
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and interpret bar graphs.
- The physical requirements of the position include standing, walking, sitting, using hands and fingers, reaching with hands and arms, use of vision (including discerning colors), talking, and hearing. Frequently, bending, kneeling, crouching, stooping, climbing ladders/stairs (including vertical ladders to rooftops), and crawling apply.
- The position requires the use of PPE including fall protection, confined space, and electrical safety. The position requires reading documents, working on a computer with keyboard and mouse, discerning colors, discerning the feel of textures, manipulating small dosage units, and using a magnifying glass. Work is performed both in an office and manufacturing environment. Ability to wear safety shoes, eye protection, and using respirators are required.
- Emails using outlook, teams, MS offices (Word, Excel, Power point), be able to use computer applications.
- Manual and power tools for general maintenance.
- Computer, Telephone, Copy and fax machines.
About KBI:
KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500 customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.
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.