Validation Lead

About This Role

The Validation Lead will strategically and operationally oversee the validation program at Thermo Fisher Scientific, ensuring GxP computerized systems and processes are continuously validated and compliant. This role involves leading end-to-end validation activities, managing system stability, and resolving complex compliance issues through risk-based methodologies. The Validation Lead will partner cross-functionally to deliver compliant solutions and drive continuous improvement.

Responsibilities

• Partner with cross-functional teams to plan, execute, and sustain compliant Validation, Sterilization, Stability, and Computer Software Validation (CSV) programs.
• Lead lifecycle management and change control activities, ensuring systems and processes remain compliant and consistent.
• Perform and oversee complex validation activities for computerized systems, equipment, processes, products, and stability programs.
• Assess, troubleshoot, and resolve validation- and system-related issues using a risk-based approach.
• Drive electronic batch record (EBR) changes and associated change management processes.
• Ensure scalable, flexible, and globally aligned validation solutions through coordination with global counterparts.
• Provide technical leadership and support for product sterilization and validation strategies.
• Lead validation-related audits, inspections, and responses, including preparation of technical justifications and defenses.
• Support customer inquiries and escalations related to validation and compliance.
• Define validation requirements, resource needs, and execution plans for new and existing systems.
• Act as the principal technical expert and escalation point for validation-related issues.
• Represent Validation on project teams, ensuring cGMP compliance and cross-functional alignment.
• Interpret and apply regulatory requirements to ensure ongoing compliance.
• Stay current with emerging technologies, regulatory trends, and industry best practices, serving as a trusted technical resource.
• Provide coaching, training, and technical guidance to team members to support development and performance.
• Foster a culture of accountability, collaboration, and quality ownership.

Requirements

• 6+ years of validation experience
• 8+ years of experience in the Medical Device and/or Pharmaceutical industry
• Bachelor's degree or higher in a Science or Engineering discipline
• Advanced knowledge of statistical concepts and data analysis
• Strong understanding of IT/CSV methodologies and regulatory standards (GAMP 5, ISO 13485, 21 CFR Part 11, EU Annex 11, Data Integrity principles)
• Proven experience leading validation lifecycle activities in regulated environments
• Ability to understand and communicate complex technical concepts effectively
• Excellent written and verbal communication skills

Qualifications

• Bachelor's degree or higher in a Science or Engineering discipline
• Minimum 6+ years of validation experience and 8+ years of experience in the Medical Device and/or Pharmaceutical industry.

Skills

* Required skills