GxP QA Engineer - Equipment Calibration & Software

Scorpion Therapeutics; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Prime Medicine is seeking a Senior Quality Engineering Specialist to join its quality assurance team in Cambridge. You will support GxP software, equipment qualification, calibration, and vendor oversight in a regulated biotech environment.

The role emphasizes IQ/OQ/PQ execution, validation document reviews, and supplier audits, with cross-functional collaboration and readiness for inspections.

Qualifications

• Bachelor's degree in a scientific, engineering, or technical field and 4+ years in regulated life sciences.
• Experience with equipment qualification, software validation/CSV, and supplier quality required.
• Knowledge of GxP, audits, and compliance documentation is essential.

Responsibilities

• Execute IQ/OQ/PQ qualification activities and draft validation protocols.
• Conduct risk-based vendor assessments and support supplier audits.
• Maintain compliance documentation and QA records.
• Oversee calibration and preventive maintenance schedules.
• Participate in audits and inspection readiness.

Skills

IQ/OQ/PQ

Software validation

CSV (Computerized System Validation)

Vendor assessments

GxP compliance

Education

Bachelor's degree in science/engineering

Tools

Calibration management software

Quality Management System (QMS)

Job description

Prime Medicine is seeking a Senior Quality Engineering Specialist to join its quality assurance team in Cambridge. You will support GxP software, equipment qualification, calibration, and vendor oversight in a regulated biotech environment.

The role emphasizes IQ/OQ/PQ execution, validation document reviews, and supplier audits, with cross-functional collaboration and readiness for inspections.