Senior Quality Engineering Specialist

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

Company Overview

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.For more information, please visit www.primemedicine.com .

Company Overview

Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types.Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities.For more information, please visit www.primemedicine.com .

About the role

Department: Quality Assurance

Reports to: VP, Quality Assurance

Location: Cambridge, MA

Position Summary

The Senior Quality Engineering Specialist provides hands‑on operational support for Prime Medicine's GxP software, equipment, calibration, preventive maintenance, and vendor oversight activities. Working with Quality, Laboratory Operations, IT/Informatics, system and equipment owners, and external vendors, the Specialist executes qualification activities, maintains accurate records, coordinates scheduled work, and helps keep systems and equipment compliant and inspection‑ready. The role also conducts risk‑based assessments of software vendors in accordance with current FDA guidance, as well as assessments of equipment and material suppliers and service providers, to ensure the quality and reliability of externally supplied inputs.

Key Responsibilities

Software Assurance and Vendor Assessments

• 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.

Equipment Qualification and Maintenance

• 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.

Supplier Quality and Quality Systems Support

• Conduct supplier audits and remote assessments under the direction of Supplier