Senior CSV/CSA Validation Lead (Remote)

Rochester Regional Health

City of Rochester (NY)

Remote

USD 130,000 - 155,000

Full time

2 days ago

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Job summary

Rochester Regional Health seeks a Lead CSV/CSA Specialist to drive validation leadership for complex GxP IT systems, overseeing planning, execution, documentation, and lifecycle activities. You will partner with IT and Quality Assurance, mentor junior team members, and ensure compliance with internal procedures and regulatory expectations.

Responsibilities include authoring validation deliverables, supporting audits, and advancing risk-based validation strategies while maintaining

Qualifications

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field.
7+ years experience in CSV/CSA, GxPIT quality, validation, or regulated system lifecycle.
Equivalent combination of education and relevant experience.
Preferred: CSV/CSA, GAMP 5, SDLC, data integrity, e-records/e-signatures.

Responsibilities

Lead validation leadership for assigned GxP IT systems and changes, coordinating across project teams, IT system owners, QA, vendors, and stakeholders.
Author, review, and approve validation deliverables and ensure traceability, risk assessment, and inspection-readiness.
Support regulatory, quality, and audits including internal/client/regulatory inspections and CAPA remediation.
Maintain validated state through lifecycle activities, change control, and release readiness across validated systems.
Mentor CSV/CSA specialists and drive continuous improvement of SOPs, templates, and training.