GxP Quality Engineer: Systems, Equipment & Vendors

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

Benefits offered by this job

401(k) match

Equity programs

Paid time off

Job summary

Prime Medicine in Cambridge, MA is seeking a Senior Quality Engineering Specialist to provide hands-on support for GxP software, equipment qualification, calibration, preventive maintenance, and vendor oversight. You will work with Quality, Laboratory Operations, IT/Informatics, and external vendors to execute qualification activities, maintain records, and ensure systems are inspection-ready.

A Bachelor's degree and at least four years in a regulated life-sciences environment are required;

Qualifications

• Bachelor’s degree in a scientific, engineering, technical, or quality‑related field, or equivalent relevant experience.
• Strong technical writing, organization, and cross‑functional coordination skills.
• Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records.
• Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements.

Responsibilities

• Draft, execute, and review software assurance test scripts using approved requirements, specifications, risk assessments, and intended-use documentation.
• Support quality oversight of GxP computerized systems, including AI-enabled software tools, in accordance with company procedures and applicable regulatory expectations.
• Conduct and document risk-based assessments of software, equipment, material, and service providers.
• Collect and review vendor questionnaires, certifications, audit materials, quality agreements, and other supporting evidence.
• Work with IT/Informatics, system owners, Quality colleagues, and vendors to resolve documentation or performance gaps and complete assigned actions.
• Draft, execute, and review equipment qualification protocols, including IQ/OQ/PQ activities.
• Review executed protocols, reports, raw data, test results, certificates, and supporting records for completeness, accuracy, and consistency.
• Support the documentation and investigation of equipment qualification discrepancies; maintain equipment, calibration, and preventive maintenance records in the computerized maintenance management system.
• Review and electronically maintain calibration certificates, maintenance records, and service reports, ensuring proper linkage to equipment.
• Oversee scheduled calibration, maintenance, and service activities with equipment owners and external providers, escalating delays and compliance risks promptly.
• Conduct supplier audits and remote assessments; prepare assessment plans, reports, follow-up actions.
• Track vendor corrective actions and other quality actions through closure.
• Support change controls, deviations, CAPAs, and other quality records involving software, equipment, calibration, maintenance, or vendors.
• Maintain trackers, dashboards, and status reports for qualification activities, calibration and maintenance schedules, vendor assessments, and open actions.
• Identify recurring issues, documentation gaps, overdue activities, and opportunities for practical process improvement.
• Participate in audits, regulatory inspections, and inspection-readiness activities as needed.

Skills

Technical writing

Cross-functional coordination

Record keeping

Risk assessment

Education

Bachelor’s degree in a scientific/engineering/technical/quality‑related field

Tools

CMMS

Calibration system

Equipment tracking system

Job description

Prime Medicine in Cambridge, MA is seeking a Senior Quality Engineering Specialist to provide hands-on support for GxP software, equipment qualification, calibration, preventive maintenance, and vendor oversight. You will work with Quality, Laboratory Operations, IT/Informatics, and external vendors to execute qualification activities, maintain records, and ensure systems are inspection-ready.

A Bachelor's degree and at least four years in a regulated life-sciences environment are required;