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Senior Quality Engineering Specialist

Prime Medicine· Quality
Apply on company site
Cambridge, MA$111k - $123kFull-timePosted 1mo ago

About the role

Senior Quality Engineering Specialist providing hands-on operational support for GxP software, equipment, calibration, preventive maintenance, and vendor oversight. Performs qualification activities, maintains records, coordinates scheduled work, and supports inspection readiness. Conducts risk-based assessments of software vendors and equipment/material/service providers to ensure quality and reliability of externally supplied inputs.

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 documentation is complete and properly linked to 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 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.

Skills

Required:Software assurance / CSVEquipment qualification (IQ/OQ/PQ)Calibration and maintenance oversightVendor / Supplier qualityGxP documentation

Benefits

  • Total Rewards package with health, financial, and wellness benefits—including medical, dental, vision, life insurance
  • 401(k) match, equity programs
  • generous paid time off, wellness days, and company-wide recharge breaks
Last updated Sep 16, 2026. Interested? Apply on the company site.

About Prime Medicine

Delivering on the promise of Prime Editing

Prime Medicine™ was founded with a goal of transforming the lives of patients with debilitating diseases through the application of our groundbreaking Prime Editing platform and technology.

next- generation gene editingPrime Editinggene editingtherapeutic applications
Company profileWebsite

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