Validation Specialist (Computer Systems Validation)

Location: Rensselaer, New York, United States

Salary: $77,000 per year

Company

hirify.global provides staffing and employment services for technical and regulated-industry roles.

What you will do

• Manage site and global Computer Systems Validation projects from initiation through completion.
• Create validation deliverables, execution templates, and comprehensive CSV risk assessments.
• Own change records, CAPAs, and quality events for CSV projects.
• Support audits and inspections as a subject matter expert.
• Partner with laboratory operations on antivirus coverage, backups, supported operating systems, patching, and infrastructure risk assessments.
• Maintain software and hardware inventories and report project, SOP, audit, and compliance metrics.

Requirements

• Bachelor’s degree in Information Technology, Computer Science, or a related technical field.
• At least 3 years of hands-on experience in quality assurance, Computer Systems Validation, and/or information technology.
• Experience with data integrity principles, compliance frameworks including 21 CFR Part 11 and Annex 11, SOP generation, and system risk management.
• Experience in pharmaceutical, biotech, medical device, or highly regulated laboratory operations is preferred.
• Role location: Rensselaer, New York, United States.

Culture & Benefits

• Temporary assignments lasting 13 weeks or longer may include medical, dental, vision, and 401(k) benefits.
• Statutory sick pay is provided where required.
• Reasonable accommodations are available during the employment process.
• Employment eligibility may be verified through E-Verify in applicable locations.