Senior Quality Engineering Specialist

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 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.

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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.

• 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…