Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Are you ready to advance your career with a world-class team? At Thermo Fisher Scientific, we seek an ambitious, highly skilled Validation Engineer II for our validation department in Tilburg. You will ensure flawless execution of equipment, utilities, facilities qualification, and process validation activities. You will work closely with technical, development, quality, and production teams to meet world-class validation standards.Job Description:Proven hands-on experience in Commissioning & Qualification and Validation gained in a highly regulated environment within a pharmaceutical setting or equivalentDemonstrates expertise in crafting new equipment, changing processes, growing production, and successfully implementing new productsCo-drafts User Requirement Specifications (URS) with suppliers and the multi-disciplinary teamDrafts validation plans and performs implementation of protocols for C&Q/IQ/OQ/PQ related to equipment, utility, processes, cleaning and computer validation, including final reports and advice on periodical review frequenciesAbility to extract information from systems and generate Periodic Review Reports for critical equipment/utilities/processes, including Continued Process Verification (CPV)Provides validation technical support within other departmentsDrafts, reviews, and amends procedures, Validation Master Plan, and other validation audited documentsResponsible for ensuring the validated status of all cGMP-critical automated process applications and quality systemsRemains abreast of current developments and regulations for the pharmaceutical industryActs as a validation SME for internal and external auditsQualifications requirements:Preference for candidates with a bachelor's degree or equivalent experience in technology, science, or a related field, and a willingness to learn. Prior experience in validation, GMP, or pharmaceutical manufacturing is required. This role offers an outstanding opportunity for learning and growth in various areas.Personal:Integrity, Intensity, Innovation, and Involvement are core characteristics we expect of all members of our organization. If you enjoy leading change and working within a matrix organization to improve internal processes, you will discover happiness in this role!