Remote Lead CSV/CSA Validation Architect

Rochester Regional Health; Oregon; Ibrido; USD 130.000 - 155.000; Tempo pieno

Descrizione del lavoro

Rochester Regional Health seeks a Lead CSV/CSA Specialist to drive validation leadership across GxP IT systems. You will oversee validation planning, testing, documentation, and lifecycle activities, partnering with IT and Quality Assurance to ensure inspection-ready deliverables.

The role requires strong writing and stakeholder engagement, mentoring junior staff, and applying risk-based validation to complex laboratory, clinical, and enterprise systems while maintaining compliance with 21 CFR

Competenze

• Bachelor's degree or equivalent with 7+ years in CSV/CSA and GxP IT quality.
• Experience with validated computerized systems and lifecycle activities.
• Strong technical writing and risk-based validation practices.

Mansioni

• Lead validation planning and oversight for new systems and upgrades.
• Author and review validation lifecycle deliverables and tests.
• Support audits, regulatory inspections, and CAPAs as SME.
• Mentor CSV/CSA specialists and improve SOPs and templates.

Conoscenze

Validation leadership

Regulatory knowledge

Documentation

Stakeholder engagement

Formazione

Bachelor's degree

Descrizione del lavoro

Rochester Regional Health seeks a Lead CSV/CSA Specialist to drive validation leadership across GxP IT systems. You will oversee validation planning, testing, documentation, and lifecycle activities, partnering with IT and Quality Assurance to ensure inspection-ready deliverables.

The role requires strong writing and stakeholder engagement, mentoring junior staff, and applying risk-based validation to complex laboratory, clinical, and enterprise systems while maintaining compliance with 21 CFR