Computer Systems Validation Engineer

Computer Systems Validation (CSV) Engineer

📍 Portsmouth, NH (On-site, full-time)

We are seeking a Computer Systems Validation Engineer to support operations within a GMP-regulated environment. This role focuses on implementing industry best practices within GAMP frameworks, ensuring compliance with regulatory requirements, and maintaining validation integrity across critical systems. You’ll also provide guidance to junior team members and act as a subject matter expert during audits and inspections.

Key Responsibilities

• Lead validation activities, ensuring effective communication, prioritization, and timely delivery.
• Maintain expertise in 21 CFR Part 11, Data Integrity, ICH Q7A, GAMP , and related regulations.
• Execute Quality Systems processes : Change Control, Deviations, CAPAs, and Validation Maintenance .
• Draft and review protocols, risk assessments, test scripts, and GMP documentation.
• Own and maintain CSV SOPs and departmental procedures.
• Act as SME during audits and inspections.
• Mentor and train junior validation team members.

What You’ll Bring

💡 This is a 100% on-site role in Portsmouth, NH . Relocation within commuting range is required.