Lead CSV Engineer (Remote) - Scale Validation for GxP

Regulatory Jobs; United States; Remote; USD 150,000 - 178,000; Full time

Job summary

Praxis Precision Medicines is seeking a Lead Computer System Validation Engineer to shape CSV strategy across a growing GxP technology portfolio. You will own validation scope, develop capabilities, and lead a team through risk-based validation while balancing compliance and speed.

You will collaborate with Quality, IT, vendors, and process owners to deliver scalable, practical validation across multiple computerized systems and regulatory inspections.

Qualifications

• Bachelor's degree in engineering, computer science, life sciences, or related field or equivalent experience.
• Significant experience in regulated biotechnology/pharma environments.
• Strong CSV/CSA, quality systems, and data integrity knowledge.
• Ability to lead validation across multiple computerized systems.
• Experience supporting regulatory inspections and audits.
• Knowledge of GxP, GAMP 5, 21 CFR Part 11 and EU Annex 11, ALCOA+.
• Familiarity with scripting, SQL, and test automation is advantageous.

Responsibilities

• Define and scale the CSV capability across IT, defining strategy and risk-based approach.
• Author, review, execute, and maintain validation deliverables (IV&V, plans, tests).
• Build and develop the CSV team (hiring, onboarding, mentoring).
• Apply risk-based scope to determine validation depth and evidence.
• Coordinate qualification and verification activities (IQ/OQ/PQ/UAT).
• Assess changes to validated systems and manage change control processes.
• Perform validation maintenance and revalidation activities as needed.
• Assist investigations of deviations and CAPA with compliant resolution.
• Prepare validation records for audits and inspections.
• Collaborate with stakeholders to implement scalable validation strategies.

Skills

CSV expertise

GxP knowledge

regulatory inspections

risk-based validation

data integrity

test automation

SQL scripting

Education

Bachelor's degree or equivalent

Tools

SQL

Test automation

Electronic document management

Issue tracking

Quality management software

Job description

Praxis Precision Medicines is seeking a Lead Computer System Validation Engineer to shape CSV strategy across a growing GxP technology portfolio. You will own validation scope, develop capabilities, and lead a team through risk-based validation while balancing compliance and speed.

You will collaborate with Quality, IT, vendors, and process owners to deliver scalable, practical validation across multiple computerized systems and regulatory inspections.