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
