Senior GxP Quality Engineer — Software, Equipment & Vendors

Prime Medicine, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 111,000 - 123,000; Full time

Job summary

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

You will coordinate qualification activities, maintain records, and ensure inspection readiness across quality, lab operations, IT, and external providers. The role includes risk-based assessments of software and supplier inputs per FDA guidance, maintaining calibration certificates, and leading QA

Qualifications

• Bachelor’s degree in a scientific, engineering, technical, or quality-related field, or equivalent relevant experience.
• At least four years of experience in a regulated life-sciences environment, including experience in equipment qualification, software assurance/CSV, calibration or maintenance oversight, supplier quality, or a related quality function.
• Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance requirements.
• Experience drafting, executing, or reviewing qualification protocols, test scripts, assessments, or other controlled quality records.
• Experience using a computerized maintenance management, calibration management, or equipment tracking system.
• Strong technical writing, organization, and cross-functional coordination skills.
• Ability to manage multiple operational priorities, maintain accurate records, and elevate risks or delays promptly.

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 that documentation is complete and properly linked to the applicable 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 under the direction of Supplier Quality leadership.
• Prepare assessment plans, document requests, questionnaires, reports, and follow-up actions.
• Track vendor corrective actions and other assigned 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

GxP software

CSV (computerized systems validation)

Calibration oversight

Equipment qualification

Documentation control

Cross-functional coordination

Technical writing

Education

Bachelor's degree in a scientific/engineering/quality field

Tools

CMMS

Calibration management system

QA/QC software

Job description

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

You will coordinate qualification activities, maintain records, and ensure inspection readiness across quality, lab operations, IT, and external providers. The role includes risk-based assessments of software and supplier inputs per FDA guidance, maintaining calibration certificates, and leading QA