Sr Manager, Facilities Maintenance

About the Role

The Sr. Manager - Facilities Maintenance will manage day-to-day utilities operations, maintenance strategies, repairs, troubleshooting, outage response, and vendor management for FLBT. This role supports facilities, utilities, and process equipment including 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, air handling units, chillers, boilers, and wastewater treatment systems.

This position will also provide support during new facilities and equipment installation, collaborating with Engineering, Calibration, Operations, Automation, Validation, Quality departments, contractors, and consultants. The role works closely with Environment, Health and Safety (EHS), Procurement/Facilities Support, and Engineering to ensure a safe workplace and develop repair/spare parts strategies.

Responsibilities

• Lead day-to-day operations of the maintenance group, handling multiple priorities and delegating tasks to appropriate trades.
• Evaluate, develop, schedule, and/or conduct training for facilities, utilities, and maintenance personnel on new or existing equipment/systems, ensuring updates to SOPs and procedures (PMs, Calibrations, etc.).
• Support Reliability Centered Maintenance (RCM) activities, including condition monitoring and predictive technologies.
• Respond to and support outages and plant-wide emergencies.
• Support facilities, utilities, and equipment IQ/OQ/PQ or other validation activities as required.
• Ensure accurate documentation of maintenance activities (PM, CM, emergency work orders) through adherence to cGDP.
• Maintain regular communication with production and support teams to execute planned maintenance and address issues promptly.
• Communicate effectively with contractors, Validation, Quality Assurance, Quality Control, Operations, Engineers, OEM providers, and internal equipment owners/operators.
• Ensure compliance with internal quality protocols, SOPs, cGMP, and FDA regulatory guidelines.
• Oversee specialized contractors to ensure facilities and equipment are delivered/maintained as prescribed.
• Develop, implement, maintain, and monitor departmental KPIs for efficiency.
• Manage SOPs, PMs, and JHAs for Facilities/Utilities areas.
• Ensure departmental cGMP compliance through up-to-date training files and mandatory training requirements.
• Maintain a safe work environment through adherence to safety guidelines, policies, and procedures.
• Demonstrate continuous personal growth in job knowledge, technical proficiency, and problem-solving.
• Maintain a positive, professional, and customer-oriented attitude.
• Hire, train, develop, and evaluate maintenance operations staff; take corrective action as needed.
• Ensure compliance with federal, state, and local regulations in consultation with the Director of Facilities and HR.
• Perform all other duties as needed.

Requirements

• Strong leadership qualities and skills.
• Understanding of plant and clean utilities system operation and cGMP requirements, with the ability to instruct others.
• Knowledge of cGMP requirements and design for clean rooms, including HVAC pressure cascades, pressurization, room air changes, and environmental controls.
• Strong technical troubleshooting and problem-solving skills.
• Knowledge of operation and maintenance of utilities/process systems, with the ability to train direct reports and peers.
• Experience with corrective maintenance, troubleshooting systemic problems, and using tools/equipment for maintenance tasks.
• Ability to use blueprints, equipment manuals, specifications, and SOPs to make informed decisions during equipment malfunctions.
• Ability to generate and manage Change Controls and perform Deviation investigations.
• Ability to develop clear procedures for equipment, utilities, and maintenance operations.
• Knowledge of NFPA 70E requirements for safe work practices and ability to guide direct reports and contractors.
• Knowledge of FDA, OSHA, EH&S, EPA, and Texas state requirements, with the ability to guide direct reports and contractors.
• Strong written, verbal, and interpersonal communication skills.
• Ability to work in a fast-paced, state-of-the-art research and manufacturing facility.
• Ability to work effectively without constant supervision and lead a team of 10+ maintenance supervisors/skilled technicians.
• Working knowledge of MS Office products (Word, Excel, Outlook, PowerPoint).
• High level of personal organizational skills, experience, and drive.
• Vision for a fully organized Facilities Maintenance department in a highly regulated GMP environment.
• Knowledge of preventative maintenance development using a GMP Computerized Maintenance Management System (CMMS).

Qualifications

• Bachelor’s degree in maintenance/facilities or related discipline with a minimum of eight (8) years of qualified experience in a pharma/biotech manufacturing facility, preferably FDA-regulated, OR
• Associate’s degree in maintenance/facilities or related discipline with a minimum of ten (10) years of qualified experience in a pharma/biotech manufacturing facility, preferably FDA-regulated, OR
• High school diploma or GED in maintenance/facilities or related discipline with a minimum of twelve (12) years of qualified experience in a pharma/biotech manufacturing facility, preferably FDA-regulated.
• Minimum of five (5) 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.
• Experience developing technician training/qualification programs.
• Wide range of maintenance and trade experience, including mechanical/electrical systems, variable frequency drives, pumps, electric motors, and PLC operations.

Working Conditions & Physical Requirements

The physical demands described are representative of those required to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities.

• Prolonged periods of sitting, standing, walking, bending, stooping, and stretching.
• Hand-eye coordination and manual dexterity to operate tools, instruments, and office equipment.
• Regularly lift and move objects weighing up to 50 pounds.
• Climb ladders and stairs of varying heights.
• Work in wet, humid, outdoor, or noisy environments.
• Provide support during off-shifts, weekends, and holidays as needed.
• Offer 24/7 support for company activities.
• Maintain mandatory attendance.