Associate Manager, GMP Maintenance
Core
Leads a team of Maintenance Technicians to execute planned and corrective maintenance on GMP manufacturing and laboratory equipment, ensuring regulatory compliance and infrastructure reliability.
Role type
Associate Manager, GMP Maintenance
Builds
Reliable GMP manufacturing and laboratory infrastructure for gene therapy production
Domain
Biotechnology / Gene Therapy / cGMP Manufacturing
Deliverable
infrastructure
Required skills
Preventive and corrective maintenance of complex manufacturing equipment, team leadership, regulatory compliance (GMP), CMMS management, vendor oversight, spare parts inventory management, calibration coordination, cross-functional collaboration
Preferred skills
Leadership experience, familiarity with GMP/ISO/FDA documentation practices, experience with BMRAM or similar CMMS systems
Technologies
Blue Mountain RAM (BMRAM), CMMS systems
Responsibilities
Assess and monitor GMP equipment condition, develop preventive maintenance plans, execute maintenance activities on GMP/non-GMP assets, oversee external contractors, provide data insights for capital investments, maintain accurate maintenance records in CMMS, support equipment handovers and restart verifications, perform calibrations
Seniority
Associate Manager, hands-on leadership