IT Validation Engineer

Role Overview

• Execute validation activities for GxP computerized systems using a risk-based Computer Software Assurance (CSA) approach.
• Author and maintain validation deliverables, including Validation Plans, Risk Assessments, Test Scripts and Protocols, and Validation Summary Reports.
• Support full system lifecycle activities, including implementation, change control, periodic review, and system retirement.
• Ensure all validation documentation is inspection-ready and aligned with internal procedures and global regulatory requirements.
• Partner with IT and business stakeholders to support onboarding and implementation of new systems.
• Provide validation guidance during system selection, configuration, and release to ensure compliance and scalability.
• Participate in change control assessments, evaluating the impact of system changes and enhancements on validated state.
• Serve as the validation lead for key GxP platforms, including Veeva Vault (eQMS, QualityDocs, Training) and other regulated systems.
• Ensure systems remain in a validated state in compliance with 21 CFR Part 11, EU Annex 11, and data integrity principles, including ALCOA+.
• Collaborate with IT and system owners to support system enhancements, releases, and ongoing periodic reviews.
• Support IT due diligence and qualification of third-party vendors and supplier systems used in GxP environments.
• Assess supplier validation packages, documentation, and control frameworks to ensure compliance with internal and regulatory standards.
• Partner with Quality to evaluate risks, define mitigation strategies, and maintain effective supplier oversight.
• Maintain continuous inspection readiness by ensuring completeness and accuracy of validation documentation, audit trails, and supporting artifacts.
• Support internal audits, mock inspections, and regulatory inspections, including direct interaction with agencies such as the U.S. Food and Drug Administration and European Medicines Agency.
• Proactively identify compliance gaps and drive remediation efforts to strengthen the overall validation and quality posture.
• Act as the primary IT partner to Quality for validation, compliance, and data integrity-related activities.
• Collaborate cross-functionally with Quality Systems, Clinical QA, Regulatory, and other GxP functions to align on validation strategy, risk management, and governance.
• Support the development and continuous improvement of validation procedures, templates, and processes.
• Provide training and guidance to system owners and stakeholders on validation requirements and best practices.

Requirements

• Bachelor’s degree in Computer Science, Information Systems, Life Sciences, or a related discipline.
• A minimum of 6 years of experience in IT validation, Computer System Validation (CSV), or GxP-regulated systems within biotechnology, pharmaceutical, or similarly regulated environments.
• Demonstrated hands-on expertise in CSV methodologies, including execution of IQ, OQ, PQ, and UAT activities.
• Strong working knowledge of Computer Software Assurance (CSA) principles, 21 CFR Part 11 and broader GxP regulatory requirements, and data integrity standards, including ALCOA+.
• Proven ability to independently author and manage validation documentation across the full system lifecycle, from planning through execution and final reporting.
• Experience with eQMS, document management systems, and/or clinical systems is preferred.
• Direct experience supporting or owning validation activities for GxP systems such as Veeva Vault, eQMS platforms, or comparable regulated applications.
• Experience performing supplier system assessments and managing vendor-provided validation documentation.
• Strong cross-functional collaboration skills, with a demonstrated ability to partner effectively with Quality, IT, and business stakeholders.
• High level of attention to detail, with a focus on documentation accuracy and inspection readiness.
• Ability to operate with a high degree of ownership, accountability, and autonomy in a fast-paced, regulated environment.

Tech Stack

• Vault

Benefits

• bonus
• benefits
• participation in Company’s stock plan