Senior Quality Engineer - GxP Systems, Equipment & Vendors

primemedicine; Cambridge (MA); On-site; USD 110,000 - 165,000; Full time

Job summary

Prime Medicine in Cambridge, MA is seeking a Senior Quality Engineering Specialist to provide hands-on operational support for GxP software, calibration, preventive maintenance, and vendor oversight. You will work with Quality, Laboratory Operations, IT/Informatics, system owners, and external vendors to ensure compliance and inspection readiness.

The role includes qualification of software and equipment, maintenance record management, risk-based assessments, and ensuring reliability of

Responsibilities

• Draft, execute, and review software assurance test scripts using approved requirements, specifications, risk assessments, and intended-use documentation.
• Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities.
• Conduct supplier audits and remote assessments under the direction of Supplier Quality.

Skills

Quality Assurance

GxP Software

IQ/OQ/PQ

Risk Assessment

Vendor Audits

Documentation

Cross-functional Collaboration

Tools

CMMS

Audit Management Software

Job description

Prime Medicine in Cambridge, MA is seeking a Senior Quality Engineering Specialist to provide hands-on operational support for GxP software, calibration, preventive maintenance, and vendor oversight. You will work with Quality, Laboratory Operations, IT/Informatics, system owners, and external vendors to ensure compliance and inspection readiness.

The role includes qualification of software and equipment, maintenance record management, risk-based assessments, and ensuring reliability of