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 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.

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 escalate risks or delays promptly.

Preferred Experience

• Experience in biotechnology, gene therapy, cell therapy, or another regulated life sciences environment.
• Familiarity with equipment lifecycle activities (URS, IQ/OQ/PQ, periodic review, calibration, maintenance) or software assurance/CSV practices.
• Experience supporting supplier qualification, vendor assessments, or laboratory instruments and CMMS records.