Senior CSV/CSA Lead: Validation & Compliance (Remote)

ACM Global Laboratories, Inc.; City of Rochester (NY); Hybrid; USD 130,000 - 155,000; Full time

Job summary

ACM Global Laboratories, Inc. is seeking a Lead CSV/CSA Specialist in IT to drive validation planning, execution, and documentation for complex GxP computerized systems.

This remote role prioritizes East Coast alignment and works with IT, QA, and vendors to ensure lifecycle control and inspection readiness. The ideal candidate will mentor junior staff, apply risk-based validation methods, and deliver high-quality evidence across system changes, integrations, and retirements, maintaining data

Qualifications

• Bachelor's degree or equivalent in a related field
• 7+ years of experience in CSV/CSA, GxP IT quality, validation, or regulated system lifecycle

Responsibilities

• Lead validation and assurance planning for new systems, upgrades, and changes across the lifecycle.
• Author, review, and oversee validation deliverables such as risk assessments, plans, URS, specs, test protocols, and VSRs.
• Support audits, inspections, deviations, CAPAs, and remediation activities.
• Mentor CSV/CSA specialists and drive continuous improvement in SOPs and templates.
• Collaborate with IT, QA, vendors, and stakeholders to ensure inspection readiness.

Skills

CSV/CSA

GxP

Regulatory compliance

Risk-based validation

Documentation writing

Mentoring

Cross-functional collaboration

Education

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field

Equivalent combination of education and relevant experience

Tools

GAMP 5

21 CFR Part 11

Job description

ACM Global Laboratories, Inc. is seeking a Lead CSV/CSA Specialist in IT to drive validation planning, execution, and documentation for complex GxP computerized systems.

This remote role prioritizes East Coast alignment and works with IT, QA, and vendors to ensure lifecycle control and inspection readiness. The ideal candidate will mentor junior staff, apply risk-based validation methods, and deliver high-quality evidence across system changes, integrations, and retirements, maintaining data