Systems Validation Specialist

Job Title: Systems Validation Specialist

Location: Madbury, New Hampshire, United States

Type: Full Time

Our client is seeking a Computer Systems Validation (CSV) Specialist II to support and enhance compliance across regulated systems. This role plays a key part in ensuring computerized systems meet internal standards and industry regulations, while also providing guidance to team members and supporting validation initiatives across projects.

**Location

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Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.

Role Overview

The CSV Specialist II will evaluate new and existing systems to ensure compliance with quality standards and regulatory requirements. This includes risk assessments, review of system changes, validation documentation, and collaboration with cross-functional teams. The role also involves acting as a QA validation representative on both small and large-scale projects.

What Our Client Offers

• A collaborative and inclusive team environment
• Strong opportunities for career advancement and professional growth
• Exposure to advanced tools and technologies
• Competitive compensation and comprehensive benefits
• Supportive leadership and mentorship
• Commitment to ethical, sustainable business practices

Key Responsibilities

• Manage and support Quality Management System (QMS) processes including Change Control, Deviations, and CAPAs
• Lead CSV activities for smaller-scale projects and contribute to larger initiatives
• Execute and oversee validation and qualification activities for systems such as DeltaV and Syncade
• Perform ongoing validation maintenance of computerized systems
• Review and update standard operating procedures (SOPs) related to CSV
• Evaluate engineering and technical documentation (e.g., P\&IDs, specifications, SOPs)
• Support internal and external audits, inspections, and compliance reviews

Required Qualifications

• Bachelor’s degree in Computer Science, Engineering, or a related discipline
• 0–4 years of experience in Computer Systems Validation
• At least 1 year of experience with automation/control systems such as PLCs, SCADA, DCS, BAS, BMS, or MES (DeltaV experience preferred)
• Experience supporting or leading projects involving CAPAs and deviation management
• Background in regulated industries such as biotechnology, pharmaceuticals, or medical devices
• Strong attention to detail and ability to manage deadlines effectively
• Ability to work independently in an on-site environment