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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How Will You Make an Impact?

The Validation Lead plays a critical role in enabling Thermo Fisher Scientific’s mission by ensuring systems, processes, and products are compliant, reliable, and fit for purpose throughout their lifecycle. This role provides strategic and operational oversight of the validation program, ensuring GxP computerized systems and processes are maintained in a validated state.

You will lead validation activities end-to-end, including the development, review, and approval of validation documentation; execution of risk assessments; determination of validation scope; and impact assessments for proposed changes. The Validation Lead applies risk-based methodologies to manage system stability, validation, and compliance while driving continuous improvement initiatives and resolving complex compliance issues. This role partners cross-functionally to deliver compliant solutions efficiently and ensures consistent policy application across the organization.

What Will You Do?

Position Overview

The Validation Lead will manage validation activities across Validation, Sterilization, Stability, and Computer Software Validation (CSV), supporting multiple sites within the Single Use Technology Division. The role requires strong collaboration, technical leadership, and accountability to ensure timely execution of validation activities that meet both regulatory and business objectives. The ideal candidate demonstrates Thermo Fisher’s competencies of Collaboration, Customer Focus, and Continuous Improvement while delivering compliant, scalable solutions.

Key Responsibilities

+ Partner with cross-functional teams to plan, execute, and sustain compliant Validation, Sterilization, Stability, and 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.

+ Perform additional duties as required to support business objectives.

How Will You Get There?

Education

+ Bachelor’s degree or higher in a Science or Engineering discipline.

Experience

+ Minimum 6+ years of validation experience.

+ 8+ years of experience in the Medical Device and/or Pharmaceutical industry.

Knowledge, Skills, and Abilities

+ Advanced knowledge of statistical concepts and data analysis.

+ Strong understanding of IT/CSV methodologies and regulatory standards, including GAMP 5, ISO 13485, 21 CFR Part 11, EU Annex 11, and Data Integrity principles.

+ Proven experience leading validation lifecycle activities in regulated environments.

+ Ability to understand and communicate complex technical concepts clearly and effectively.

+ Excellent written and verbal communication skills, with the ability to influence and collaborate across all organizational levels.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.