Technicien administratif au sein de Desjardins Group offrant un environnement de travail hybride. Engagement envers l'équité, la diversité et l'inclusion pour tous les employés.
About the role
- 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
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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