Sr Manager, Facilities Maintenance

Job Description

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.

• 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 new 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, Engineers, OEM providers, as well as internal equipment owners and operators, for successful management of the facilities 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 prescribed.
• 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.