GMP Facility Operations Manager overseeing facility operations and ensuring Good Manufacturing Practices at Emory University. Responsible for equipment maintenance, cleaning services, and compliance with safety protocols and regulatory standards.
Responsibilities
Oversee the physical operations of the facility, ensuring Good Manufacturing Practices (GMP) compliance for facilities and equipment
Manage vendors/service calls
Maintain critical systems (HVAC, WFI) for product quality, safety, and regulatory adherence
Manage scheduling of equipment maintenance to meet FDA GMP guidelines
Establish and oversee facility cleaning services and schedule
Manage all equipment/room alarm systems
Interface with Emory Hospital for alarm notifications
Lead IQ/OQ/PQ for all equipment onboarding and qualification
Ensure adherence to cGMP, FDA, and internal standards; manage documentation, CAPAs, and lead audits
Oversee preventative/predictive maintenance for critical systems (HVAC, WFI, refrigeration)
Select, manage, and coordinate external service providers for projects and maintenance
Develop, manage, and control facility budgets; oversee facility upgrades and capital projects
Manage gowning, cleaning/sanitization programs, and product changeovers
Enforce safety protocols
Lead equipment/environment specific risk assessments
Ensure environmental compliance
Work with QA/QC, Production, and other departments
Requirements
Bachelor's degree in engineering, facilities management, or business administration
4+ years experience overseeing facility operations for a GMP facility or an equivalent combination of education and experience
Experience in regulated environments (pharma/biotech)
Strong knowledge of FDA/GMP regulations, quality systems (SOPs, validation, audits)
Previous supervisory experience preferred
Strong understanding of GMP, GDP (Good Distribution Practices)
Experience with HVAC, WFI, steam systems
Leadership, communication, problem-solving, and project management skills
Ability to work in hazardous/cleanroom environments
Benefits
Working in a laboratory
Working with human blood, body fluids, tissues, or other potentially infectious materials
Job title
Facilities Operations Manager – Good Manufacturing Practices
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