Senior GMP Maintenance Technician
Core
Ensure availability, reliability, safety, and compliance of GMP and non-GMP process and support equipment in a new manufacturing facility.
Role type
Senior GMP Maintenance Technician (Sole Contributor)
Builds
GMP manufacturing operations for mRNA therapeutics
Domain
Biopharmaceuticals / GMP Manufacturing
Required skills
cGMP compliance, Root Cause Analysis (RCA), Preventive and Corrective Maintenance planning, CMMS ownership, PLC troubleshooting, Pneumatics and vacuum systems, High-speed packaging machinery, Vendor management, EHS/LOTO enforcement, Technical documentation (SOPs, CAPAs), Lean/6S, Reliability Centered Maintenance (RCM), Failure Mode and Effects Analysis (FMEA)
Preferred skills
Generative AI tools, Capital project management, URS development, FAT/SAT/IOQ support, OJT training delivery
Technologies
Maximo, SAP PM, Excel, Word, PowerPoint
Responsibilities
Own equipment uptime and reliability within an assigned area; Lead structured troubleshooting and RCA for complex equipment issues; Plan and coordinate preventative and corrective maintenance (PM/CM); Author, review, and improve maintenance procedures and plans; Act as a technical escalation point and coach colleagues; Lead small capital projects and reliability initiatives; Manage external vendors and contractors; Champion EHS by enforcing LOTO and safe systems of work; Support regulatory inspections and internal audits; Support 24/7 operations including night shifts and callouts.
Seniority
Senior, hands-on IC