Lead CSV Engineer — Remote Validation Strategy

Praxis Precision Medicines, Inc.; Boston (MA); On-site; 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 a growing GxP tech portfolio. You will build capabilities, shape processes, and balance compliance with speed as Praxis scales.

You will partner with Quality, IT, business owners, and vendors to deliver pragmatic, risk-based validation across multiple computerized systems, driving continuous improvement and ensuring data integrity for patient safety and product quality.

Qualifications

• Bachelor's degree in engineering, computer science, information systems, life sciences, or related discipline.
• Significant experience in biotech/pharmaceuticals or other regulated environments.
• Strong experience with CSV, CSA, quality systems, and data integrity principles.
• Ability to lead validation activities across multiple computerized systems and projects.
• Experience supporting regulatory inspections, audits, and quality-system documentation.
• Knowledge of GxP, GAMP 5, 21 CFR Part 11 and EU Annex 11 (as applicable).
• Experience authoring/ reviewing IQ, OQ, PQ, UAT, or equivalent verifications.
• Familiarity with scripting, SQL, test automation, EDM, or issue-tracking tools is advantageous.

Responsibilities

• Lead and scale the CSV capability across IT with strategy, standards, and risk-based approach.
• Author, review, execute, and maintain validation deliverables (IQ/OQ/PQ, test scripts, traces).
• Build the CSV team through hiring, onboarding, and mentoring.
• Apply risk-based scope and evidence requirements based on use, patient safety, product quality, data integrity, and regulatory impact.
• Coordinate qualification and verification activities (installation, operation, performance, UAT).
• Assess changes to validated systems, support regression testing, and ensure changes go through change control.
• Perform validation maintenance activities, including periodic reviews and revalidation assessments.
• Support investigation and resolution of validation deviations, test exceptions, and CAPAs.
• Prepare validation records and evidence packages for audits and inspections.
• Collaborate with system owners, Quality, IT, and vendors to translate needs into pragmatic validation strategies.
• Own and continuously improve validation procedures, templates, and training for a lean biotech org.
• Use automation and AI-assisted tools to improve efficiency with independent review.

Skills

Leadership

Risk-based thinking

Cross-functional collaboration

Quality mindset

Regulatory awareness

Education

Bachelor's degree in engineering or related field

Tools

SQL

Scripting

Test automation

Electronic document management

Issue-tracking tools

Job description

Praxis Precision Medicines, Inc. is seeking a Lead Computer System Validation Engineer to own validation strategy across a growing GxP tech portfolio. You will build capabilities, shape processes, and balance compliance with speed as Praxis scales.

You will partner with Quality, IT, business owners, and vendors to deliver pragmatic, risk-based validation across multiple computerized systems, driving continuous improvement and ensuring data integrity for patient safety and product quality.