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← Praxis Precision Medicines, Inc.

Computer Systems Validation Engineer

Praxis Precision Medicines, Inc.
Location
United States - Remote
Posted
1 month ago
Department
IT
What they actually want (must-haves)
  • Bachelor's degree in engineering, computer science, information systems, life sciences, or a related discipline; equivalent relevant experience may be considered
  • Significant experience working in biotechnology, pharmaceutical, medical device, healthcare, or another regulated environment
  • Strong experience with Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles
  • Demonstrated ability to lead validation activities across multiple computerized systems and projects
  • Experience supporting regulatory inspections, audits, validation assessments, and quality-system documentation
  • Strong knowledge of GxP requirements, GAMP 5 and risk-based CSV/CSA principles, 21 CFR Part 11 and EU Annex 11, ALCOA+ data integrity principles
Nice to have
  • Familiarity with scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools
What the job really is

The Computer Systems Validation Engineer at Praxis will lead the validation strategy for their GxP technology portfolio, focusing on developing and scaling the Computer System Validation (CSV) capabilities. This role involves collaborating with various teams to ensure compliance and data integrity while implementing risk-based validation approaches. Responsibilities include authoring validation documents, executing testing, and mentoring team members as the organization grows.

Benefits
  • 99% of the premium paid for medical, dental and vision plans
  • Company-paid life insurance, AD&D, disability benefits, and voluntary plans
  • 401(k) match dollar-for-dollar up to 6% on eligible contributions
  • Long-term stock incentives and Employee Stock Purchase Plan (ESPP)
  • Discretionary quarterly bonus
  • Flexible wellness benefit
Things to weigh
  • Remote position with required travel
  • Role involves significant leadership and strategic responsibilities
  • Focus on building and developing a team as the organization grows
Job score3.6/5
Benefits4/5
Freshness4/5
Career value5/5
Role clarity5/5
Pay transparency0/5

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