Senior GxP Quality Engineer — Software, Equipment & Vendors

Prime Medicine, Inc.; Cambridge (MA); Híbrido; USD 111.000 - 123.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

GxP software

CSV (computerized systems validation)

Calibration oversight

Equipment qualification

Documentation control

Cross-functional coordination

Technical writing

Educación

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

Herramientas

CMMS

Calibration management system

QA/QC software

Descripción del empleo

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 .

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.

U.S. Pay Range

$111,000 — $123,000 USD

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.