U
Posted 4 hours ago
Supervisor, GMP Facilities
UltragenyxSupervisor, GMP Facilities
Perks & benefits
VisaPaid LeaveHealth InsuranceEducation Allowance
Requirements
Associate or bachelor’s degree in engineering or Facilities Management, 6+ years GMP maintenance experience, 2+ years supervisory experience, Knowledge of GMP, FDA, and EMA, Proficiency with CMMS, Familiarity with HVAC and clean utilities
Skills
GMPCMMSHVAC
About the role
Responsibilities
- Supervise and coordinate daily activities of maintenance technicians and contractors
- Ensure all maintenance work complies with GMP, safety, and environmental regulations
- Plan, schedule, and manage preventive and corrective maintenance schedules for GMP-critical equipment
- Maintain accurate documentation in the Computerized Maintenance Management System (CMMS)
- Lead troubleshooting efforts and conduct root cause analysis for equipment failures
- Collaborate with Quality Assurance, Manufacturing, and Engineering teams
- Participate in audits and inspections conducted by internal teams and regulatory agencies
- Train and mentor maintenance staff on GMP procedures and technical skills
- Support deviation investigations and CAPA management
Requirements
- Associate or bachelor’s degree in engineering, Facilities Management, or related field
- 6+ years of maintenance experience in a GMP-regulated pharmaceutical, biotech, or medical device environment
- 2+ years of supervisory or team lead experience in maintenance or facilities
- Strong knowledge of GMP, FDA, EMA, and regulatory requirements
- Proficiency with CMMS (e.g., Blue Mountain, Infor EAM, Maximo) and Microsoft Office
- Familiarity with HVAC, clean utilities (WFI, clean steam, compressed air), and critical manufacturing equipment
- Experience supporting deviation investigations, root cause analysis, and CAPA implementation
- Ability to read and interpret technical drawings and engineering specifications
Benefits
- Generous vacation time and public holidays
- Volunteer days
- Long term incentive and Employee stock purchase plans
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans
About the Company
Ultragenyx is a biopharma company dedicated to leading the future of rare disease medicine by following the science and creating life-changing treatments.
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Ultragenyx · Bedford
