Senior CSV/CSA Validation Lead – Remote

951 ACM Medical Labs, Inc; United States; Remote; USD 130,000 - 155,000; Full time

Job summary

Rochester Regional Health is seeking a Senior CSV/CSA Specialist for a remote role on the East Coast. You will lead validation planning, execution, and lifecycle activities for complex GxP computerized systems, partnering with IT and Quality Assurance, mentoring junior staff, and ensuring systems comply with internal procedures and regulatory expectations.

You will translate governance requirements into practical, risk-based, and inspection-ready project execution, overseeing validation

Qualifications

• Bachelor's degree in CS/IS/Eng/Life Sciences or equivalent with 7+ years in CSV/CSA
• Strong knowledge of CSV, CSA, GAMP 5, SDLC, data integrity, and 21 CFR Part 11
• Experience leading validation strategy for complex systems and audits

Responsibilities

• Lead validation planning and execution for new systems, upgrades and changes
• Coordinate validation activities across IT, QA, vendors, and stakeholders
• Prepare and review validation deliverables (plans, risk assessments, test protocols, traceability matrices) and ensure inspection readiness
• Mentor CSV/CSA staff and drive continuous improvement in SOPs and templates

Skills

CSV/CSA validation

GxP/Regulatory

Technical writing

Mentoring

Risk-based planning

Education

Bachelor's degree or equivalent

Job description

Rochester Regional Health is seeking a Senior CSV/CSA Specialist for a remote role on the East Coast. You will lead validation planning, execution, and lifecycle activities for complex GxP computerized systems, partnering with IT and Quality Assurance, mentoring junior staff, and ensuring systems comply with internal procedures and regulatory expectations.

You will translate governance requirements into practical, risk-based, and inspection-ready project execution, overseeing validation