Sr Manager, Facilities Maintenance

The Sr. Manager - Facilities Maintenance, under the leadership of the Director of Facilities , will be responsible for managi ng the day-to-day utilities operation s, maintenance strategies, repairs and troubleshooting support , outages response and vendor management on behalf of FLBT . Facilities, utilities and process equipment includ es 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, O perations , Automation, Validation and Quality department personnel, and with the various contractors and consultants working on the project s . This position will work closely with E nvironment, 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

Es s e n t i a l F u n c ti on s:

• 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 .
• Responsible for evaluating, developing, scheduling and /or conducting training to facilities, utilities and /or maintenance personnel about n ew or existing equipment /systems and ensure such training is reflected in current SOPs and other procedures (PMs, Calibrations, etc.) as required .
• Support Reliability Centered Maintenance (RCM) activities including condition monitoring and predictive technologies as applicable.
• Responsible to respond and support outages and plant-wide emergencies.
• Responsible to support facilities, utilities, and equipment IQ/OQ/PQ or any other validation activity as required .
• Ensure accurate documentation of maintenance activities such as PM, CM and emergency work orders through adherence of cGDP .
• Maintain regular communication with production and support area counterparts to ensure planned maintenance activities are executed effectively and any issues are addressed promptly.
• Communicate effectively with Contractors, Validation, Quality Assurance, Quality Control, Operations, E ngineers, OEM providers, as well as internal equipment owners and op erators, for successful management of the f acilities department in F L BT.
• Ensure compliance, as set forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility .
• 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 pr e scribed.
• Develop, implement, maintain , and monitor departmental KPIs to ensure a high level of efficiency.
• Responsible for all Facilities/Utilities areas SOPs, PMs, JHA’s.
• 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.
• Ensure a safe work environment is maintained through adherence and compliance with safety guidelines, policies, and site procedures .
• Demonstrate continuous personal pursuit to increasing job knowledge, proficiency in technical understanding, and problem-solving abilities.
• Maintain a positive, professional, and customer-oriented attitude.
• 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 .
• All other duties as needed.
  
  

Re q ui r ed S k ill s & A b i l i t i e s :

• Strong leadership qualities and skills.
• Strong understanding of plant and clean utilities system operation and applicable cGMP requirements with the ability to instruct and guide others on those requirements.
• Strong understanding o f cGMP requirements and design for clean room s including HVAC pressure cascades, pressurization, room air changes and environmental controls .
• 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.
• 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.
• k nowledge using blueprints , equipment manuals, specifications, standard operating procedures, and be able to use proper judgement when taking corrective actions during equipment malfunction.
• Must be able to generate and manage Change Controls and perform Deviation investigations.
• Must be able to develop clear procedures for equipment , utilities and maintenance operations.
• K nowledge of NFPA 70E requirements for safe work practices and be able to guide direct reports and contractors in such requirements.
• K nowledge of FDA, OSHA, EH&S, EPA, and state of Texas requirements and be able to guide direct reports and contractors in such requirements.
• Knowledge and understanding of OSHA regulations, and safe work practices.
• Strong written, verbal and interpersonal communications skills.
• Desire to work in a fast paced, state of the art , alternately research and customized manufacturing facility.
• 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.
• Working knowledge of MS Office products (Word, Excel, Outlook, and PowerPoint ).
• 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.
• Knowledge of preventative maintenance development using a GMP Computerized Maintenance management System (CMMS) required .
  
  

W o r Ki n g Co n Di Ti On s & P h y Sic a l R e q Ui r Em e n Ts

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 :

• Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching.
• Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment.
• Regularly lift and move objects weighing up to 50 pounds.
• Climb ladders and stairs of varying heights.
• Work under conditions that may be wet or humid.
• Provide support during off shifts, weekends, and holidays as needed.
• Work in outdoor weather conditions and noisy environments.
• Offer 24/7 support for company activities.
• Maintain mandatory attendance.
  
  

Minimum Q u a Li f Ications

• 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
• 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
• 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
• A minimum of five (5) or more years of previous leadership experience.
  
  

Preferred Qualifications

• Knowledge of Blue Mountain Regulatory Asset Manager CCMS/CMMS.
• Knowledge of Trackwise quality management software .
• Knowledge of bio-processing equipment, and single use technology .
• Experien ce with development of t echnician training / qualification program .
• A wide range of maintenance and trade experience is a plus, including mechanical /electrical systems, variable frequency drives, pumps, electric motors , and PLC o perations.
  
  

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.