Senior CSV/CSA Specialist (GxP)

Location: Remote, East Coast preferred; Rochester, NY

Salary: $105,000–$130,000 annually

Company

hirify.global operates in a regulated laboratory and healthcare environment.

What you will do

• Lead risk-based validation and assurance activities for GxP computerized systems across implementation, operation, change, migration, archival, and retirement.
• Author, review, and approve validation deliverables, including risk assessments, validation plans, specifications, testing protocols, traceability matrices, and validation summary reports.
• Provide IT Quality and Compliance oversight for SDLC activities, change controls, lifecycle processes, and system documentation.
• Support audits, inspections, CAPAs, deviations, remediation plans, and responses to validation-related findings.
• Guide change impact assessments, regression testing, periodic reviews, access and security reviews, backup and restore reviews, and release readiness.
• Mentor CSV/CSA specialists and improve validation procedures, templates, guidance, training materials, and metrics.

Requirements

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field, or an equivalent combination of education and experience.
• At least 5 years of experience in CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems.
• Strong knowledge of computerized system validation, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, and electronic records and signatures.
• Experience with validation lifecycle deliverables, risk-based validation, audits, inspections, CAPAs, deviations, remediation, testing evidence, and change controls.
• Ability to lead complex validation activities across multiple systems, projects, stakeholders, and priorities.
• Remote work is based in the United States, with East Coast location preferred.

Culture & Benefits

• Full-time schedule of 40 hours per week, Monday through Friday during daytime hours.
• Primarily sedentary, computer-based work requiring prolonged sitting and sustained concentration.
• Work includes cross-functional collaboration, independent decision-making, and frequent information processing.
• Healthcare-environment requirements may include TB screening, flexible hours, or a valid driver’s license depending on the program.