Senior CQV Engineer

Work ScheduleStandard Office Hours (40/wk)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionJoin Thermo Fisher Scientific Inc. as a Sr CQV Engineer and become part of a great team in Switzerland! This is an outstanding opportunity to work with a world-class company committed to making the world healthier, cleaner, and safer. We value collaboration and innovation, and we are excited to welcome an experienced individual who shares our dedication to excellence.ResponsibilitiesPrepares, reviews and approves production, validation, audit reports documents, procedures, and rationalesEvaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports; performs gap analysis to resolve efficiencies and take appropriate actionsDefines, in collaboration with other partners (Quality Assurance, System Owner…) the requalification strategy of GMP systems and implements it, including maintaining the quality system and complete practical activitiesCoordinates execution of activities by external contractorsPerforms requalification and revalidation Work Orders, including routine and non-routine operations, and documents in forms and OMX following Good Documentation PracticesParticipates in the culture of continuous improvement and development of technologiesIdentifies training needs and develop training programs.Works in a safe and responsible manner in order to build an injury-free and incident-free workplaceParticipates in calibration activitiesRequirementsBachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field + 10 years experienceOr Master's degree + 3 years in the engineering field, preferably in the pharmaceutical, or chemical process industryFunctional knowledge of cGMPs and manufacturing operations in FDA regulated facilityExperience in the pharmaceutical industry for qualification & validation is requiredExperience of multi-cultural work environmentExcellent verbal and written communication skills in English and preferably German or another European languageStrong understanding of GMP standards and regulatory requirementsExcellent technical writing skills with attention to detailProficiency in PC applications, including MS OfficeStrong communication and interpersonal skillsCertification in technical writing or quality managementExperience with electronic documentation management systems (e.g., Documentum, TrackWise)If you are driven and excited to support our mission, we would love to hear from you. Apply today and take the next step in your career with Thermo Fisher Scientific Inc.!