Facilities Manager at Astrix in Indianapolis, Indiana

Job Description:

Facilities Manager

Our client is seeking a Facilities Manager at a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.

Salary Range: $110K - $130K

Location: 100% on site - Brownsburg, IN

Duties and Assignment:Project

• On-site supervisor for completion of facility: cleanrooms/labs, office renovation, hot cells
• Support 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/BMS

Liaison with service providers

• Primary point of contact; supervise on-site work
• Obtain competitive quotes, select vendors, negotiate pricing, approve POs/vendor bills, cultivate relationships
• Manage contracts (e.g., pest control, fire monitoring/suppression, landscaping/snow, equipment PM/repair, custodial services)

Assist with

• Safety programs: radiation, laboratory, occupational
• Facility licensing/compliance: RAM, effluents/emissions, sewer water/storm water, building codes (fire/electrical)
• Cleanrooms: Participate in cleaning, IQ/OQ/PQ
• Establish a system for scheduling/recording: warranties, inspections, PMs, repairs

Production Stage

Priority: Facility ready to produce GMP doses

• On-call to react to alarms/emergencies/urgent facilities problems that might cause production delays
• Inspections/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, requalification
• Documents for facility: Draft/review SOPs, IQ/OQ/PQ, other protocols/reports
• Assist with budget forecasting of CapEx/OpEx
• Waste management: RAM, chemical, garbage, recycling
• Assist with investigations for Quality Unit (deviations/OOS/recalls/FMEAs)
• Facility renovations/expansions: planning, bidding, selection/contracting, design, project management

All Stages

• Frequent facility inspections inside/outside
• Expert on the facility for inspectors/management/staff
• Review/approve documents: quotes/contracts, PMs, final reports, invoices
• Manage badge access system

Experience/Education

• 5+ years in facilities management, including 2+ years in pharmaceuticals
• 2+ years in cleanroom environments
• Experience with equipment installation, IQ/OQ/PQ, calibration, PM, troubleshooting, and basic repairs
• Experience with radiopharmaceuticals
• Proficiency in QMS, BMS, EMS software systems
• Technical writing for SOPs, protocols, and reports

Apply Now