Senior Quality Engineering Specialist

Scorpion Therapeutics

Cambridge (MA)

On-site

USD 120,000 - 180,000

Full time

7 days ago

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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

Role

Senior Quality Engineering Specialist supporting GxP software, equipment, calibration, and vendor oversight within Prime Medicine’s quality assurance team.

Responsibilities

execute qualification activities (IQ/OQ/PQ), draft and review validation protocols, conduct risk-based vendor assessments, support supplier audits, and maintain compliance documentation
oversee calibration and preventive maintenance schedules
participate in audits and inspection readiness.

Requirements

Bachelor’s in a scientific, engineering, or technical field; 4+ years in regulated life sciences, with experience in equipment qualification, software validation/CSV, and supplier quality.

HighValue

biotech/gene therapy environment, GxP compliance, equipment qualification, software assurance, vendor assessments, and calibration management.

WorkSetup

based in Cambridge, MA, with operational support and cross-functional collaboration.

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