Senior Quality Engineering Specialist (Biotechnology)

Location: Cambridge, MA, United States

Salary: $111,000–$123,000 USD annual base salary, plus eligible short-term and long-term incentive awards.

Company

hirify.global develops gene editing therapies using its proprietary Prime Editing platform, with programs in hematology, immunology and oncology, liver, and lung diseases.

What you will do

• Draft, execute, and review software assurance test scripts and equipment qualification protocols, including IQ/OQ/PQ activities.
• Provide quality oversight for GxP computerized systems, including AI-enabled software tools, equipment, calibration, and preventive maintenance activities.
• Conduct risk-based assessments of software, equipment, material, and service providers, including supplier audits and remote assessments.
• Review qualification records, raw data, certificates, maintenance documentation, vendor evidence, and quality agreements for completeness and accuracy.
• Coordinate calibration, maintenance, service activities, corrective actions, change controls, deviations, and CAPAs through closure.
• Maintain trackers, dashboards, and quality records while supporting audits, regulatory inspections, and inspection-readiness activities.

Requirements

• 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.
• Working knowledge of GxP documentation, data integrity, computerized systems, equipment qualification, calibration, and preventive maintenance.
• Experience drafting, executing, or reviewing qualification protocols, test scripts, risk assessments, or other controlled quality records.
• Experience using a computerized maintenance management, calibration management, or equipment tracking system.
• Strong technical writing, organization, cross-functional coordination, and risk escalation skills.

Nice to have

• Experience in biotechnology, gene therapy, cell therapy, or another regulated life-sciences environment.
• Familiarity with equipment lifecycle activities such as URS, IQ/OQ/PQ, periodic review, calibration, and maintenance.
• Experience with supplier qualification, vendor assessments, laboratory instruments, or CMMS records.

Culture & Benefits

• Comprehensive medical, dental, vision, life insurance, financial, and wellness benefits.
• 401(k) matching and equity programs.
• Generous paid time off, wellness days, and company-wide recharge breaks.
• Equal opportunity employment practices.