Senior CSV/CSA Specialist — Remote Validation Leader

Rochester Regional Health; City of Rochester (NY); Remote; USD 105,000 - 130,000; Full time

Job summary

Rochester Regional Health is seeking a Senior CSV/CSA Specialist to lead risk-based validation and assurance of GxP computerized systems across their lifecycle. The role provides technical leadership in validation strategy, data integrity, audit readiness, and regulatory compliance, while mentoring junior CSV/CSA staff.

The position is remote with East Coast preference, offering 40 hours per week. You will collaborate with IT and Quality teams to support audits, inspections, and lifecycle

Qualifications

• Bachelor's degree or equivalent in a related field.
• 5+ years of CSV/CSA, IT quality, software validation, change control, SDLC, or GxP systems experience.

Responsibilities

• Lead planning, execution, review, and approval of validation deliverables for new GxP systems and upgrades.
• Conduct risk assessments, validation strategy reviews, and supplier assessments.
• Ensure validation documentation is complete, traceable, and inspection-ready.
• Provide technical review and mentorship to CSV/CSA team members.

Skills

CSV/CSA experience

Regulatory compliance

IT quality

Education

Bachelor's degree in CS/IS/Engineering/Life Sciences/Quality or related field

Job description

Rochester Regional Health is seeking a Senior CSV/CSA Specialist to lead risk-based validation and assurance of GxP computerized systems across their lifecycle. The role provides technical leadership in validation strategy, data integrity, audit readiness, and regulatory compliance, while mentoring junior CSV/CSA staff.

The position is remote with East Coast preference, offering 40 hours per week. You will collaborate with IT and Quality teams to support audits, inspections, and lifecycle