Lead CSV/CSA Validation Architect (Remote)

Rochester Regional Health; United States; Remote; USD 130,000 - 155,000; Full time

Benefits offered by this job

Remote work

Job summary

Rochester Regional Health is seeking a Lead CSV/CSA Specialist to serve as the primary validation lead for complex GxP computerized system projects. You will oversee validation planning, execution, documentation, and lifecycle activities, partnering with IT and Quality Assurance while mentoring junior staff.

Remote role with East Coast preference, 40 hours per week, Monday–Friday schedule. The position focuses on risk-based validation, inspection readiness, and regulatory compliance across

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field
• 7+ years of CSV/CSA, GxP quality, validation, or regulated system lifecycle experience
• Experience leading validation strategy and deliverables for complex systems
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity principles
• Strong writing, mentoring, and stakeholder management skills

Responsibilities

• Lead validation and assurance planning for new systems, upgrades, integrations, infrastructure changes, software changes, configuration changes, and retirements
• Author, review, approve, or oversee validation deliverables including risk assessments, V&V plans, URS, FS/DS, test protocols, traceability matrices, validation reports
• Support regulatory inspections, audits, deviations, CAPAs, and remediation plans; provide SME guidance on evidence expectations
• Maintain lifecycle control through change impact assessments, regression testing, periodic reviews, and security reviews
• Mentor CSV/CSA staff and drive continuous improvement of SOPs, templates, and portfolio practices

Skills

Leadership

Project management

Regulatory knowledge

Risk-based validation

Documentation quality

Stakeholder engagement

Education

Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field

Job description

Rochester Regional Health is seeking a Lead CSV/CSA Specialist to serve as the primary validation lead for complex GxP computerized system projects. You will oversee validation planning, execution, documentation, and lifecycle activities, partnering with IT and Quality Assurance while mentoring junior staff.

Remote role with East Coast preference, 40 hours per week, Monday–Friday schedule. The position focuses on risk-based validation, inspection readiness, and regulatory compliance across