Praxis Precision Medicines, Inc.
Computer Systems Validation Engineer
- Confirmed live in the last 24 hours
- $150k–$178k
- Mid level
- United States - Remote
- Added 1 month ago
About this role
Praxis is seeking a Lead Computer System Validation (CSV) Engineer to shape and scale their validation strategy within a growing GxP technology portfolio. This pivotal role involves building and mentoring a CSV team, ensuring compliance with regulations, and implementing pragmatic, risk-based validation approaches. The ideal candidate will balance data integrity and regulatory adherence with business needs, driving efficiency and confidence in delivering medicines.
What you'll do
- Define and scale the Computer System Validation capability across IT.
- Author and maintain validation lifecycle documents, including plans and test scripts.
- Build and develop the CSV team through hiring and mentoring.
- Apply risk-based approaches to determine validation scope and evidence requirements.
- Execute qualification and verification activities, including various testing phases.
- Assess system changes and ensure compliance through change control procedures.
What they're looking for
- Computer System Validation (CSV)
- Risk Assessment
- Data Integrity
- Change Control
- Test Automation
- SQL
- GAMP 5
Benefits
- Medical, Dental, and Vision (99% premium paid)
- Company-paid Life Insurance and AD&D
- Disability Benefits
- Stock Incentives and ESPP
- Discretionary Quarterly Bonus
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Praxis Precision Medicines, Inc.
- Industry
- Biotech & Pharma
Likely interview questions
- Describe your experience with applying a risk-based approach to Computer System Validation.
- How would you define and implement a scalable validation strategy for a rapidly growing biotechnology organization?