Facilities Manager
Astrix - Indianapolis, IN
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Facilities ManagerOur client is seeking a Facilities Manager at a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals. Salary Range: $110K - $130KLocation: 100% on site - Brownsburg, INDuties and Assignment:ProjectOn-site supervisor for completion of facility: cleanrooms/labs, office renovation, hot cellsSupport the installation/qualification of mechanical/HVAC, electrical, plumbing, cleanrooms, hot cells, fume hoods/isolators, control systems, BMS, fire safety, etc.Heavy emphasis on HVAC/cleanrooms/BMSLiaison with service providersPrimary point of contact; supervise on-site workObtain competitive quotes, select vendors, negotiate pricing, approve POs/vendor bills, cultivate relationshipsManage contracts (e.g., pest control, fire monitoring/suppression, landscaping/snow, equipment PM/repair, custodial services)Assist withSafety programs: radiation, laboratory, occupationalFacility licensing/compliance: RAM, effluents/emissions, sewer water/storm water, building codes (fire/electrical)Cleanrooms: Participate in cleaning, IQ/OQ/PQEstablish a system for scheduling/recording: warranties, inspections, PMs, repairsProduction StagePriority: Facility ready to produce GMP dosesOn-call to react to alarms/emergencies/urgent facilities problems that might cause production delaysInspections/PM/repairs of facilities-related equipment: In-house or supervise contractors (e.g., emergency showers/eyewash, fire sprinklers/extinguishers, emergency alarms/systems, backup power transfer)Facilities equipment: Manage warranties, service contracts; schedule PMs, requalificationDocuments for facility: Draft/review SOPs, IQ/OQ/PQ, other protocols/reportsAssist with budget forecasting of CapEx/OpExWaste management: RAM, chemical, garbage, recyclingAssist with investigations for Quality Unit (deviations/OOS/recalls/FMEAs)Facility renovations/expansions: planning, bidding, selection/contracting, design, project managementAll StagesFrequent facility inspections inside/outsideExpert on the facility for inspectors/management/staffReview/approve documents: quotes/contracts, PMs, final reports, invoicesManage badge access systemExperience/Education5+ years in facilities management, including 2+ years in pharmaceuticals2+ years in cleanroom environmentsExperience with equipment installation, IQ/OQ/PQ, calibration, PM, troubleshooting, and basic repairsExperience with radiopharmaceuticalsProficiency in QMS, BMS, EMS software systemsTechnical writing for SOPs, protocols, and reports
Created: 2024-10-11