Senior Quality Engineering Specialist
Core
Provides hands-on operational support for GxP software, equipment, calibration, preventive maintenance, and vendor oversight to ensure systems and equipment remain compliant and inspection-ready.
Role type
Senior Quality Engineering Specialist (Regulatory Compliance & Operations)
Builds
Compliant GxP computerized systems, qualified laboratory equipment, and validated vendor supply chains for gene therapy development.
Domain
Biotechnology / Gene Therapy / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP documentation, data integrity, equipment qualification (IQ/OQ/PQ), calibration oversight, preventive maintenance, risk-based vendor assessments, technical writing, cross-functional coordination
Preferred skills
Biotechnology/gene therapy experience, equipment lifecycle management (URS, periodic review), supplier qualification, laboratory instrument support
Technologies
Computerized maintenance management systems (CMMS), calibration management systems, GxP computerized systems
Responsibilities
Draft and execute software assurance test scripts and equipment qualification protocols; conduct risk-based assessments of software, equipment, and service providers; maintain calibration and maintenance records; oversee scheduled calibration and service activities; support change controls, deviations, and CAPAs; participate in audits and regulatory inspections.
Seniority
Senior, hands-on IC
