Lead CSV Engineer — Remote, Modern Validation Strategy

Socket.dev; United States; On-site; USD 150,000 - 178,000; Full time

Job summary

Praxis Precision Medicines is seeking a Lead Computer System Validation Engineer to shape how CSV is done as we scale our GxP portfolio. This builder role owns validation strategy across systems, develops capabilities, and drives pragmatic, risk-based validation.

You'll partner with Quality, IT, vendors, and system owners to lead validation across initiatives, balancing compliance with speed and data integrity. Travel may be required as needed.

Qualifications

• Bachelor's degree in engineering, computer science, information systems, life sciences, or related discipline.
• Experience in biotechnology/pharmaceutical/regulatory environments.
• Strong knowledge of CSV, CSA, and data integrity concepts.
• Ability to lead validation across multiple computerized systems and teams.
• Experience supporting regulatory inspections and quality-system documentation.
• Familiarity with GxP, GAMP 5, 21 CFR Part 11 and EU Annex 11 as applicable.

Responsibilities

• Define the validation strategy and operating model for CSV across IT.
• Author, review, execute, and maintain validation deliverables (IQ/OQ/PQ, test scripts, traceability).
• Build and develop the CSV team, including hiring and mentoring CSV Engineers.
• Apply risk-based approach to determine validation scope and evidence requirements.
• Coordinate qualification and verification activities (installation, performance, UAT).
• Assess changes to validated systems and support regression testing.
• Perform maintenance activities, periodic reviews, and revalidation assessments.
• Investigate deviations, test exceptions, incidents, and CAPA where needed.
• Prepare validation records for audits and regulatory inspections.
• Collaborate with owners, Quality, IT, vendors to translate needs into deliverables.
• Own and improve validation procedures, templates, and training; leverage automation where approved.

Skills

CSV leadership

GxP validation

Data integrity

Regulatory audit support

Education

Bachelor's degree or equivalent

Tools

Scripting

SQL

Test automation

Electronic document management

Job description

Praxis Precision Medicines is seeking a Lead Computer System Validation Engineer to shape how CSV is done as we scale our GxP portfolio. This builder role owns validation strategy across systems, develops capabilities, and drives pragmatic, risk-based validation.

You'll partner with Quality, IT, vendors, and system owners to lead validation across initiatives, balancing compliance with speed and data integrity. Travel may be required as needed.