Validation Specialist

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About Thermo Fisher Scientific At Thermo Fisher Scientific, we develop solutions that help people live healthier, cleaner, and safer lives. This is more than our Mission – it is the impact our colleagues make every day. At our Vilnius site, we develop and manufacture innovative life science and diagnostic technologies used around the world. Our teams work in an environment where professionalism, collaboration, innovation, and continuous improvement matter. Job Overview We are looking for a Validation Specialist to join our Change Control and Validation Management team in Vilnius. In this role, you will support validation activities across the Vilnius site, including preparing and reviewing validation documentation, maintaining validation deliverables, and investigating the root causes of reported incidents in accordance with ISO 9001, ISO 13485, GMP, and 21 CFR Part 820 requirements. You will help ensure that validation activities meet applicable regulatory and quality requirements while working closely with cross-functional teams. You will provide guidance on validation processes, support quality and compliance activities, and contribute to continuous improvement initiatives. This opportunity may suit a validation professional who enjoys solving complex validation challenges, collaborating across functions, and contributing to a strong culture of quality excellence. Key Responsibilities • Prepare validation documentation accurately and ensure its timely completion • Lead and coordinate validation activities to achieve established objectives and maintain compliance with applicable requirements • Provide guidance and ensure that production, cleaning, shipping, and test method validation processes comply with ISO 13485 and GMP requirements • Participate in external and, where required, internal audits and complete related training activities • Recommend improvements to assigned processes, functions, and validation activities • Lead and coordinate investigations related to validation activities, including root cause analysis and the development and implementation of corrective and preventive actions (CAPAs) Experience and Qualifications • Bachelor’s or Master’s degree in Molecular Biology, Chemistry, Biochemistry, Genomics, or a related scientific field • Professional experience in Manufacturing, Quality Control (QC), Quality Assurance (QA), validation, or another relevant scientific function • Excellent written and verbal communication skills in English and Lithuanian • Strong technical writing skills, with the ability to prepare clear and accurate validation documentation • Proficiency in risk assessment, data analysis, and problem-solving Skills and Competencies • Clear verbal and written communication skills • Proficiency in Microsoft Office applications • Effective interpersonal and collaboration skills • Ability to organize priorities, make quality-related decisions, and manage multiple activities in a dynamic environment • Ability to complete projects on schedule in a deadline-oriented environment • Strong attention to detail and commitment to quality and compliance Preferred Qualifications • Experience with validation activities in a regulated manufacturing or life sciences environment • Knowledge of ISO 9001, ISO 13485, GMP, and/or 21 CFR Part 820 requirements • Experience with root cause investigations and corrective and preventive actions (CAPAs) • Experience supporting internal or external audits What We Offer • Annual performance bonus and additional financial benefits • Comprehensive health package, including private health, life and accident insurance • Wellbeing support for employees and their family members, including mental health consultations, health check-ups, vaccinations, and on-site health initiatives • Opportunities for professional growth through internal training, access to Thermo Fisher e-University, and continuous development • The opportunity to work in a global, innovation-driven organization and collaborate with international teams • Daily benefits such as subsidized meals, gym access, and company transportation • An inclusive and supportive culture, with team events and community initiatives • 2 additional paid volunteering days per year How to Apply If you are interested in validation, quality, and continuous improvement and would like to contribute to maintaining high standards across our Vilnius operations, we would be pleased to hear from you. Thank you to everyone who applies. Due to the high volume of applications, we will be able to contact only candidates selected to progress to the next stage of the recruitment process. Compensation The monthly salary range estimated for this position based in Lithuania is €2 183,33–€3 270,83.