TELECOMMUTE

notifications, establishes appropriate alarm response procedures. + Leads IQ/OQ/PQ for all equipment onboarding and qualification. + Ensures adherence to cGMP, FDA, and internal standards; manage documentation, CAPAs, and lead audits. + Oversees preventative/predictive maintenance for critical systems (HVAC, WFI, refrigeration) and equipment. + Selects, manages, and coordinates external service providers for projects and maintenance. + Develops, manages, and controls facility budgets; oversees facility upgrades and capital projects. + Manages gowning, cleaning/sanitization programs, and product changeovers. + Enforces safety protocols, leads equipment/environment specific risk assessments, and ensures environmental compliance. + Works with QA/QC, Production, and other departments. + Performs related responsibilities as required. MINIMUM QUALIFICATIONS: + Bachelor's degree in engineering, facilities management, or business administration and 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) is required. + Previous supervisory experience preferred. + Essential Skills & Qualification: Strong understanding of GMP, GDP (Good Distribution Practices). + Experience with HVAC, WFI, steam systems. Leadership, communication, problem-solving, and project management. + Ability to work in hazardous/cleanroom environments and handle physical demands. + Leadership skills to manage a team and critical infrastructure, ensuring a compliant and validated operating environment. NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee. Additional Details Emory is

**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** GMP Facility Operations Manager oversees the physical operations of the facility, ensuring Good Manufacturing Practices (GMP) compliance for facilities and equipment, managing vendors/service calls, and maintaining critical systems (HVAC, WFI) for product quality, safety, and regulatory adherence, often involving documentation, audits, and emergency response. KEY RESPONSIBILITIES: + Manages scheduling of equipment maintenance to meet FDA GMP guidelines. Establishes and oversees facility cleaning services and schedule. + Establishes equipment life cycle for anticipated annual repair/replacement costs. + Manages all equipment/room alarm systems. Interfaces with Emory Hospital for alarm