Lead CSV Engineer - Validate & Scale GxP Systems (Remote)

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 150,000 - 178,000; Full time

Benefits offered by this job

Excellent health benefits package

401(k) with match

Stock incentives & ESPP

Quarterly bonus

Generous PTO and holidays

Company-wide shutdowns

Job summary

Praxis Precision Medicines, Inc. is seeking a Lead Computer System Validation Engineer. You will own validation strategy across a growing GxP technology portfolio, shaping CSV capabilities and leading a team as Praxis scales.

In this builder role, you’ll collaborate with Quality, IT, business process owners, vendors, and technical teams to implement pragmatic, risk-based validation while maintaining data integrity and compliance across multiple systems.

Qualifications

• Bachelor's degree in engineering, computer science, information systems, life sciences, or related discipline; equivalent experience.
• Significant experience in biotech/pharma/regulated environments with CSV/CSA.
• Strong knowledge of GxP, GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity.
• Ability to lead validation across multiple computerized systems and projects, directing teams.

Responsibilities

• Define validation strategy, operating model, standards, and risk-based approach for CSV across IT.
• Author, review, execute, and maintain validation lifecycle deliverables (IQ/OQ/PQ/UAT, test scripts, traceability).
• Build CSV team through hiring, onboarding, mentoring, and development.
• Apply risk-based scope, test depth, and evidence requirements based on use, safety, quality, data integrity, and regulatory impact.
• Coordinate qualification and verification activities (installation, OQ, PQ, UAT, regression testing).
• Manage changes to validated systems via change control and revalidation as needed.
• Maintain validation records for audits and regulatory inspections; support CAPA and deviations.

Skills

GxP validation

CSV strategy

risk-based validation

regulatory inspections

21 CFR Part 11

ALCOA+ data integrity

IQ/OQ/PQ/UAT

scripting/SQL

Education

Bachelor's degree in engineering / life sciences

Tools

Validation automation tools

Electronic document management

Job description

Praxis Precision Medicines, Inc. is seeking a Lead Computer System Validation Engineer. You will own validation strategy across a growing GxP technology portfolio, shaping CSV capabilities and leading a team as Praxis scales.

In this builder role, you’ll collaborate with Quality, IT, business process owners, vendors, and technical teams to implement pragmatic, risk-based validation while maintaining data integrity and compliance across multiple systems.