Sr Manager, Facilities Maintenance

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.

Essential Functions:

• 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 FLBT.
• 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.

Required Skills &…