Senior Quality Engineering Specialist
Prime Medicine · Cambridge, MA
QualityCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Quality Engineering Specialist at a gene-editing biotech company provides operational support for GxP-regulated software, equipment, and vendor oversight. The role executes qualification activities, maintains compliance records, and conducts risk-based assessments of software vendors and suppliers.
What they're looking for
- Experience with GxP software systems and computerized system validation
- Knowledge of FDA guidance for software vendor assessment and risk evaluation
- Hands-on expertise in equipment qualification and preventive maintenance
- Ability to develop and execute test scripts based on specifications and requirements
- Strong understanding of regulatory compliance and inspection readiness protocols
What you'll be doing
- Draft, execute, and review software assurance test scripts for GxP systems
- Conduct risk-based assessments of software vendors per FDA guidance
- Support quality oversight of computerized systems including AI-enabled tools
- Maintain accurate records and coordinate scheduled qualification and maintenance activities
- Evaluate equipment, material suppliers, and service providers for quality and reliability
Privacy & handoff
This role links to Prime Medicine's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.