Senior Engineer, Maintenance
Core
Ensuring reliable operation, maintenance, and lifecycle management of sterile manufacturing process equipment and clean utility systems supporting vial filling and formulation operations.
Role type
Senior Manufacturing Engineer (Maintenance & Reliability)
Builds
Production of sterile pharmaceutical/biotech products via vial filling and formulation lines
Domain
Pharmaceutical manufacturing / Biotechnology / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment reliability engineering, Preventive and predictive maintenance planning, Root cause analysis, GMP compliance, Equipment qualification and validation, CMMS management, Capital project execution, Spare parts strategy, OEE optimization
Preferred skills
IMA sterile processing equipment expertise, TrackWise or SAP PM proficiency, Reliability Centered Maintenance (RCM), Lean Manufacturing, Six Sigma
Technologies
IBM Maximo, TrackWise, Kneat, SAP PM, HVAC systems, Autoclaves, Isolators, Vial filling machines, Sterilization tunnels
Responsibilities
Own maintenance strategy and lifecycle management for assigned sterile manufacturing equipment, Lead troubleshooting and root cause investigations to reduce downtime, Plan and execute preventive and predictive maintenance activities, Support equipment qualification, requalification, and validation activities, Lead or support change controls, deviations, and risk assessments, Develop and maintain equipment spare parts strategies and inventory optimization
Seniority
Senior, hands-on IC
