Senior Quality Engineer: GxP Software & Equipment

Prime Medicine, Inc.; Cambridge (MA); On-site; USD 111,000 - 123,000; Full time

Benefits offered by this job

401(k) match

Equity programs

Paid time off

Wellness days

Job summary

Prime Medicine, Inc. is seeking a Senior Quality Engineering Specialist in Cambridge, MA to provide hands-on support for GxP software, equipment, calibration, and vendor oversight.

You will collaborate with Quality, Laboratory Operations, IT/Informatics, and external vendors to execute qualification activities and maintain inspection-ready records. The role includes risk-based assessments of software and supplier quality, draft/review of qualification protocols, maintenance of calibration and

Qualifications

• Bachelor’s degree in a scientific, engineering, or quality field.
• 4+ years in a regulated life-sciences environment.
• Knowledge of GxP documentation and data integrity.
• Experience drafting qualification protocols and test scripts.
• Experience using a computerized maintenance management or calibration system.
• Strong writing, organization, and cross-functional coordination.

Responsibilities

• Draft and review software assurance test scripts.
• Oversee GxP computerized systems and risk assessments.
• Conduct supplier and vendor assessments.
• Maintain qualification and calibration records.
• Support change controls, CAPAs, and quality records.

Skills

GxP software

CSV (GxP)

Calibration oversight

Vendor quality audits

Documentation control

Education

Bachelor’s degree in science/engineering

Tools

CMMS

Calibration management system

Job description

Prime Medicine, Inc. is seeking a Senior Quality Engineering Specialist in Cambridge, MA to provide hands-on support for GxP software, equipment, calibration, and vendor oversight.

You will collaborate with Quality, Laboratory Operations, IT/Informatics, and external vendors to execute qualification activities and maintain inspection-ready records. The role includes risk-based assessments of software and supplier quality, draft/review of qualification protocols, maintenance of calibration and