**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **About the job** Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $40 billion and approximately 120, 000 employees globally. Are you ready to make a significant impact in the world of science and technology? We are looking for a highly skilled and diligent validation specialist to join our team. Together we will contribute to important work, like helping our customers accelerate life sciences research, solve complex analytical challenges, and improve patient diagnostics. We are committed to supporting your career goals and providing an innovative and dynamic work environment. **Position Summary:** As an Engineer II, Validation your expert knowledge of validation will be used to drive the progression of validation studies and ensure compliance with regulatory requirements. The candidate will work closely with teams across our site to direct the strategy and completion of validation activities. All aspects of validation are covered (Process, Analytical Method, Cleaning, Software, and Equipment), providing a range of opportunities with which to apply your scientific, validation, or engineering knowledge. **Key Responsibilities:** + Develop and maintain documentation for validation activities, including plans, protocols and reports. + Collaborate with multi-functional teams across manufacturing, R&D, QA, and Regulatory Affairs to ensure appropriate validation of systems. + Perform risk assessments and develop risk mitigation strategies to ensure compliance and shape validation strategy. + Provide technical expertise and guidance on validation to internal customers. + Stay up to date with industry trends and regulatory requirements related to CSV. + Participate in internal and external audits, where needed, and assist in addressing any findings. **Preferred Skills/Experience:** The QA Validation team supports all pillars of validation within the business to drive process improvements across manufacturing. We encourage candidates who thrive in a multi-disciplinary, highly technical environment where personal development and collaboration are keys to success. Sound decision-making skills in time-sensitive and sophisticated situations, with a considered assessment of risk, are essential. Demonstrated experience of handling numerous projects and priorities is a must. **Qualifications:** + Bachelor's degree in Science, Engineering, or a related field. A Master’s degree is preferred. + Proven experience in validation in a regulated industry such as pharmaceuticals, medical devices, or biotechnology. + Solid understanding of regulatory requirements, including ISO 13485 and FDA Part 820. Preferred FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. + Excellent attention to detail and ability to work independently with minimal direction. + Strong analytical and problem-solving skills. + Excellent written and verbal communication skills. **Apply today!** **http://jobs.thermofisher.com** 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.