Senior Process Engineer - Equipment
Core
Onboard new process equipment, execute commissioning/qualification, and maintain bioprocess/fill-finish/packaging equipment in a sterile cleanroom environment for gene therapies and vaccines.
Role type
Senior hands-on IC process engineer (equipment)
Builds
Biopharmaceutical products (AAV, viral vectors, vaccines) using single-use production concepts
Domain
Biopharma / Gene Therapy / Sterile Manufacturing
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (equipment lifecycle & maintenance)
Required skills
Mechanical/Electrical/Automation engineering, GMP compliance, sterile manufacturing operations, equipment troubleshooting/repair, preventive/corrective maintenance, project management, root cause analysis, SCADA integration, vendor coordination
Preferred skills
Chemical or Mechanical engineering background, experience with aseptic filling/isolator technology, knowledge of international pharmaceutical engineering standards
Technologies
CMMS, SCADA, GMP documentation systems, single-use production systems
Responsibilities
Analyze and implement engineering solutions for equipment reliability and performance; troubleshoot and optimize bioprocess and utility equipment; lead engineering projects from initiation to completion; support process scale-up, technology transfer, and validation activities; manage preventive and corrective maintenance programs; execute GMP-compliant quality systems activities (change controls, deviations, CAPAs); collaborate cross-functionally to maximize equipment uptime; provide technical leadership and training to site personnel.
Seniority
Senior, hands-on IC
