Senior CSV/CSA Specialist - Validation Leader (Remote)

951 ACM Medical Labs, Inc; United States; Remote; USD 105,000 - 130,000; Full time

Benefits offered by this job

Remote work

Job summary

Rochester Regional Health seeks a Senior CSV/CSA Specialist to lead risk-based validation of GxP computerized systems throughout their lifecycle. You will guide strategy, execution, and documentation while ensuring data integrity and regulatory compliance.

The role offers mentorship to junior staff, collaboration with IT and QA, and responsibility for validating system changes, upgrades, and retirements in a remote East Coast environment.

Qualifications

• 5+ years CSV/CSA, IT quality, software validation, change control, SDLC or GxP computerized systems experience.
• Strong knowledge of regulatory expectations (21 CFR Part 11, EU Annex 11) and data integrity concepts.
• Experience leading validation strategy and deliverable execution for varied systems.

Responsibilities

• Lead validation and assurance for new GxP systems, upgrades, integrations, and retirements.
• Author, review, or approve validation lifecycle deliverables and evidence.
• Provide IT Quality oversight and support audits, inspections, and CAPAs.
• Support lifecycle activities including procurement, implementation, validation, and change control.
• Mentor junior CSV/CSA staff and drive continuous improvement.

Skills

CSV/CSA

IT Quality

SDLC

GxP

Regulatory Knowledge

Education

Bachelor’s degree or equivalent

Job description

Rochester Regional Health seeks a Senior CSV/CSA Specialist to lead risk-based validation of GxP computerized systems throughout their lifecycle. You will guide strategy, execution, and documentation while ensuring data integrity and regulatory compliance.

The role offers mentorship to junior staff, collaboration with IT and QA, and responsibility for validating system changes, upgrades, and retirements in a remote East Coast environment.