Senior CSV/CSA Specialist (GxP)

Location: Remote, East Coast preferred; city listed as Rochester, New York.

Salary: $130,000–$155,000 per year

Company

hirify.global operates in the laboratory and regulated healthcare services space.

What you will do

• Lead validation and assurance planning for new systems, upgrades, integrations, infrastructure changes, software and configuration changes, and system retirements.
• Coordinate CSV/CSA activities across IT, Quality Assurance, system owners, vendors, business stakeholders, and project teams.
• Author, review, approve, and oversee risk assessments, validation plans, requirements, specifications, test protocols, traceability matrices, summary reports, and change impact assessments.
• Ensure validation evidence and documentation are complete, traceable, approved, and inspection-ready.
• Support audits, regulatory inspections, deviations, CAPAs, remediation plans, supplier assessments, and change control activities.
• Mentor CSV/CSA specialists and improve SOPs, templates, training materials, metrics, and portfolio practices.

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.
• 7+ years of experience in CSV/CSA, GxP IT quality, validation, quality systems, software assurance, or regulated system lifecycle activities.
• Strong knowledge of CSV, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, electronic records and electronic signatures, and risk-based validation.
• Experience leading validation strategy and deliverables for complex laboratory, quality, clinical, enterprise, infrastructure, integration, cloud/SaaS, or data systems.
• Strong technical writing, documentation review, facilitation, mentoring, stakeholder engagement, analytical, and problem-solving skills.

Nice to have

• Experience supporting audits, inspections, deviations, CAPAs, remediation activities, supplier assessments, and change control processes.
• Experience coordinating validation work across multiple stakeholders and managing review, approval, testing, evidence, and delivery activities.

Culture & Benefits

• Remote work arrangement with East Coast preference.
• Full-time schedule of 40 hours per week, Monday through Friday during daytime hours.
• Work involving cross-functional collaboration with IT, Quality Assurance, vendors, and business stakeholders.
• Sedentary, primarily computer-based role requiring sustained concentration and independent decision-making.