Lead CSV Engineer, GxP Validation & Automation (Remote)

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

Benefits offered by this job

401(k) matching up to 6%

Stock incentives & ESPP

Discretionary quarterly bonus

Flexible wellness benefit

Paid time off & holidays

Job summary

Praxis Precision Medicines is hiring a Lead Computer System Validation Engineer to shape how CSV is done as we scale. You’ll own validation strategy across a growing GxP technology portfolio, developing capabilities, and building a pragmatic, risk-based approach to ensure data integrity and compliance.

You’ll partner with Quality, IT, business process owners, vendors and technical teams to lead validation across multiple computerized system initiatives, balancing regulatory needs with business

Qualifications

• Bachelor's degree or equivalent in a related discipline and/or relevant experience.
• Significant experience in regulated environments (biotech/pharma/medical devices) with CSV/CSA.
• Deep knowledge of GxP, data integrity, and related quality processes (change control, deviations, CAPA, document control).

Responsibilities

• Define validation strategy and risk-based approach for the CSV program across IT.
• Author, review, execute, and maintain validation lifecycle deliverables (plans, requirements, risk assessments, specs, test scripts, traceability, reports).
• Build and mentor the CSV team, including hiring, onboarding, and development.
• Coordinate qualification and verification activities (IQ/OQ/PQ/UAT) and perform impact assessments for changes.
• Support audits, inspections, and regulatory documentation with well-organized evidence packages.
• Drive continuous improvement to validation procedures, templates, and automation while balancing compliance and speed.

Skills

CSV/CSA

GxP

CFR Part 11

EU Annex 11

ALCOA+

Change control

CAPA

IQ/OQ/PQ/UAT

Traceability

Regulatory inspections

SQL

Scripting

Test automation

Documentation management

Issue tracking tools

Education

Bachelor's degree in engineering, computer science, information systems, life sciences, or related discipline

Job description

Praxis Precision Medicines is hiring a Lead Computer System Validation Engineer to shape how CSV is done as we scale. You’ll own validation strategy across a growing GxP technology portfolio, developing capabilities, and building a pragmatic, risk-based approach to ensure data integrity and compliance.

You’ll partner with Quality, IT, business process owners, vendors and technical teams to lead validation across multiple computerized system initiatives, balancing regulatory needs with business