Sr. GMP Maintenance Technician
Core
Develop and execute preventative and corrective maintenance strategies for GMP manufacturing and laboratory equipment, including monitoring Building Management and Controls systems.
Role type
Senior GMP Maintenance Technician
Builds
GMP manufacturing and laboratory equipment uptime and compliance
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Preventive and corrective maintenance, GMP compliance, CMMS management, Equipment selection, Troubleshooting, SOP/WI development, Contractor supervision, Shutdown management, Safety analysis (JSA), Spare parts management
Preferred skills
Bioprocessing equipment design, Environmental control systems, Process control, Engineering design in regulated environments
Technologies
CMMS, Building Management Systems, Building Controls and Monitoring Systems
Responsibilities
Assess and provide guidance on equipment and mechanical systems during onboarding for site standardization; Participate in project reviews from concept to start-up, focusing on equipment selection; Coordinate and prioritize maintenance compliance with Quality standards; Perform or assist with new equipment installations and Site Acceptance Testing (SAT); Execute planned and corrective maintenance on GMP and non-GMP equipment per Quality and EHSS standards; Conduct periodic GMP/Safety walk-downs to identify improvement areas; Lead and support contractor services for external equipment maintenance, including quotes, scheduling, and on-site supervision; Collaborate with various departments to ensure timely equipment maintenance, minimizing downtime and ensuring smooth handovers; Support the development of Job Safety Analysis (JSAs); Review equipment performance periodically to identify and propose improvements; Report preventive maintenance findings and any equipment performance deviations; Provide feedback on maintenance procedures and update Work Instructions (WIs) and Work Plan Templates (WPTs); Maintain troubleshooting proficiency for process and utility systems; Respond to alarms and monitor trends from the Building Control and Monitoring Systems; Upload maintenance documentation into the CMMS system; Identify critical spare parts for the equipment; Manage shutdown activities and provide after-hours troubleshooting support
Seniority
Senior, hands-on IC