Sr Manager, Facilities Maintenance

** Position Overview*
* The Sr. Manager
-Facilities Maintenance,under theleadershipof the Director of Facilities,willbe responsible for managing theday-to-dayutilitiesoperations,maintenance strategies, repairs and troubleshooting support, outages response and vendor management on behalf ofFLBT. Facilities, utilities and process equipment includesbutarenot 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/condensingboilers,wastewatertreatment systems,among others.

Thispositionwill also provide support duringnew facilities and equipment installation,working withthe 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,Healthand Safety (EHS) to develop and ensure a safe workplace is developed;with Procurement/Facilities Support for development of repair parts and spare parts strategies;andwith Engineering for the technical background,installation,improvement, and reliability of the Facilities and equipment.

** Job Description*
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* + Responsible for taking a leadership role in theday-to-day operations of the maintenance group, able to handle multiple priorities quickly and efficiently and delegating tasks to appropriate tradesand skill levels.

+ Responsible for evaluating,developing,scheduling and/or conductingtrainingtofacilities,utilities and/or maintenance personnelaboutnew or existing equipment/system sand 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 respondandsupportoutages and plant-wide emergencies.

+ Responsible to support facilities, utilities, and equipment IQ/OQ/PQ or any other validation activity as required.

+ Ensureaccuratedocumentation of maintenance activities such as PM,CMand emergency work orders through adherence ofcGDP.

+ Maintain regular communication with production and support area counterparts to ensure planned maintenance activities are executedeffectivelyand any issues are addressed promptly.

+ Communicateeffectivelywith 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 inFLBT.

+ Ensure compliance, asset forth in internal quality protocols and SOPs including cGMP and FDA regulatory guidelines, within the areas of responsibility.

+ Able to work with other engineers andvalidationcontractors in directing and providing oversight of specialized contractors to ensure facility and equipment are delivered and/ormaintainedas prescribed.

+ Develop, implement,maintain, andmonitordepartmental KPIstoensurea high levelof efficiency.

+ Responsible for all Facilities/Utilities areas SOPs, PMs, JHA's.

+ Ensure departmental cGMP compliance by staying current with assigned SOPs,maintainingup-to-date training files, and meeting all mandatory training requirements, including

ADPcourses.

+ Ensure a safe work environment ismaintainedthrough adherence and compliance with safety guidelines, policies,andsite procedures.

+ Demonstrate continuous personal pursuit toincreasingjob 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 ona timely basis andin 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 asneeded.

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* + Strong leadership qualities and skills.

+ Strong understanding of plant and clean utilitiessystemoperationand applicablec

GMPrequirements with the ability to instruct and guide others on those requirements.

+ Strong understanding of cGMP requirement sand designfor clean roomsincluding

HVACpressure cascades, pressurization,room airchangesand environmental controls.

+ Strong technical troubleshooting/problem solving skills. Possessorcouldgain knowledge with respect to the operation and maintenance of various utilities/ processsystems and be able totransmitall this knowledge to direct reports and peers.

+ Knowledge of a wide variety of typical maintenance tasks including corrective maintenance,…