Position Overview:
The Sr. Manager - Facilities Maintenance, under the leadership of the Director of Facilities, will be responsible for managing the day-to-day utilities operations, maintenance strategies, repairs and troubleshooting support, outages response and vendor management on behalf of FLBT. Facilities, utilities and process equipment includes but are not limited to bioreactors, incubators, filtration skids, chromatography skids, autoclaves, freezers, refrigerators, walk-in cold rooms, QC/PD lab equipment, MCRs, MBUs, water purification and distillation units, air compressors and dryers, process gases, air handling units, air cooled chillers, steam/condensing boilers, wastewater treatment systems, among others. This position will also provide support during new facilities and equipment installation, working with the corresponding Engineering, Calibration, Operations, Automation, Validation and Quality department personnel, and with the various contractors and consultants working on the projects. This position will work closely with Environment, Health and Safety (EHS) to develop and ensure a safe workplace is developed; with Procurement/Facilities Support for development of repair parts and spare parts strategies; and with Engineering for the technical background, installation, improvement, and reliability of the Facilities and equipment.
Job Description:
Essential Functions:
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Responsible for taking a leadership role in the day-to-day operations of the maintenance group, able to handle multiple priorities quickly and efficiently and delegating tasks to appropriate trades and skill levels.
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Responsible for evaluating, developing, scheduling and/or conducting training to facilities, utilities and/or maintenance personnel about new or existing equipment/systems and ensure such training is reflected in current SOPs and other procedures (PMs, Calibrations, etc.) as required.
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Support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable.
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Responsible to respond and support outages and plant-wide emergencies.
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Responsible to support facilities, utilities, and equipment IQ/OQ/PQ or any other validation activity as required.
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Ensure accurate documentation of maintenance activities such as PM, CM and emergency work orders through adherence of cGDP.
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Maintain regular communication with production and support area counterparts to ensure planned maintenance activities are executed effectively and any issues are addressed promptly.
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Communicate effectively with Contractors, Validation, Quality Assurance, Quality Control, Operations, Engineers, OEM providers, as well as internal equipment owners and operators, for successful management of the facilities department in FLBT.
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Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility.
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Able to work with other engineers and validation contractors in directing and providing oversight of specialized contractors to ensure facility and equipment are delivered and/or maintained as prescribed.
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Develop, implement, maintain, and monitor departmental KPIs to ensure a high level of efficiency.
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Responsible for all Facilities/Utilities areas SOPs, PMs, JHA’s.
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Ensure departmental cGMP compliance by staying current with assigned SOPs, maintaining up-to-date training files, and meeting all mandatory training requirements, including ADP courses.
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Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, and site procedures.
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Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.
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Maintain a positive, professional, and customer-oriented attitude.
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Hire, train, develop and evaluate maintenance operations staff. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal, state, and local regulations in consultation with the Director of Facilities and Human Resources as appropriate.
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All other duties as needed.
Required Skills & Abilities:
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Strong leadership qualities and skills.
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Strong understanding of plant and clean utilities system operation and applicable cGMP requirements with the ability to instruct and guide others on those requirements.
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Strong understanding of cGMP requirements and design for clean rooms including HVAC pressure cascades, pressurization, room air changes and environmental controls.
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Strong technical troubleshooting / problem solving skills. Possess or could gain knowledge with respect to the operation and maintenance of various utilities / process systems and be able to transmit all this knowledge to direct reports and peers.
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Knowledge of a wide variety of typical maintenance tasks including corrective maintenance, troubleshooting systemic problems and the tools and equipment required to perform these maintenance tasks.
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knowledge using blueprints, equipment manuals, specifications, standard operating procedures, and be able to use proper judgement when taking corrective actions during equipment malfunction.
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Must be able to generate and manage Change Controls and perform Deviation investigations.
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Must be able to develop clear procedures for equipment, utilities and maintenance operations.
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Knowledge of NFPA 70E requirements for safe work practices and be able to guide direct reports and contractors in such requirements.
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Knowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements and be able to guide direct reports and contractors in such requirements.
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Knowledge and understanding of OSHA regulations, and safe work practices.
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Strong written, verbal and interpersonal communications skills.
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Desire to work in a fast paced, state of the art, alternately research and customized manufacturing facility.
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Ability to work quickly and effectively without constant supervision. Ability to lead a combination of 10+ maintenance supervisors / skilled technicians in support of facility maintenance.
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Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint).
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This role will require a high level of personal organizational skills, experience, and drive. The successful candidate must have a vision of a final state, fully organized Facilities Maintenance department in a highly regulated GMP environment.
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Knowledge of preventative maintenance development using a GMP Computerized Maintenance management System (CMMS) required.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
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Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching.
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Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment.
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Regularly lift and move objects weighing up to 50 pounds.
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Climb ladders and stairs of varying heights.
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Work under conditions that may be wet or humid.
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Provide support during off shifts, weekends, and holidays as needed.
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Work in outdoor weather conditions and noisy environments.
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Offer 24/7 support for company activities.
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Maintain mandatory attendance.
Minimum Qualifications:
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Bachelor’s degree in a maintenance/facilities or related discipline with a minimum of eight (8) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency, OR
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Associate’s degree in a maintenance/facilities or related discipline with a minimum of ten (10) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency, OR
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High school diploma or general education degree (GED) in a maintenance/facilities or related discipline with a minimum of twelve (12) years of qualified experience in a maintenance/facilities or related role within a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency
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A minimum of five (5) or more years of previous leadership experience.
Preferred Qualifications:
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Knowledge of Blue Mountain Regulatory Asset Manager CCMS/CMMS.
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Knowledge of Trackwise quality management software.
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Knowledge of bio-processing equipment, and single use technology.
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Experience with development of technician training / qualification program.
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A wide range of maintenance and trade experience is a plus, including mechanical/electrical systems, variable frequency drives, pumps, electric motors, and PLC operations.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
