Lead CSV Engineer — Remote, Risk-Based Validation

Praxis Precision Medicines, Inc.; United States; Remote; USD 150,000 - 178,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking a Lead Computer System Validation Engineer to own validation strategy across our GxP technology portfolio and build CSV capabilities as we scale.

You'll lead validation across multiple computerized systems, coordinate with Quality, IT, and vendors, and drive risk-based, compliant validation that enables faster delivery of meaningful medicines to patients while maintaining data integrity and quality standards.

Qualifications

• Bachelor’s degree required or equivalent experience in a related field.
• Significant experience in biotechnology/pharma/regulated environment.

Responsibilities

• Lead and scale the CSV capability across IT, defining strategy and risk-based approach while building the CSV team.
• Author, review, execute, and maintain validation lifecycle deliverables (plans, requirements, risk assessments, specs, test scripts, traceability, validation reports).
• Coordinate qualification and verification activities (IQ/OQ/PQ/UAT) and manage changes through change control.
• Prepare validation records for audits and inspections; collaborate with system owners, Quality, IT, and vendors to translate needs into validated deliverables.

Skills

CSV expertise

GxP knowledge

Data integrity

Regulatory readiness

Leadership

Risk-based validation

Education

Bachelor's degree in engineering, CS, information systems, life sciences

Tools

Scripting

SQL

Test automation

EDMS

Issue tracking tools

Job description

Praxis Precision Medicines, Inc. is seeking a Lead Computer System Validation Engineer to own validation strategy across our GxP technology portfolio and build CSV capabilities as we scale.

You'll lead validation across multiple computerized systems, coordinate with Quality, IT, and vendors, and drive risk-based, compliant validation that enables faster delivery of meaningful medicines to patients while maintaining data integrity and quality standards.