Qualification Engineer

The Qualification Engineer is part of the qualification team which is responsible for performing qualification and maintaining the qualified state of manufacturing equipment, utilities & facilities (e.g. HVAC) and the qualification process.AccountabilitiesQualification and validationEquipment qualificationComputer system and automation validationMaintain the qualified status of manufacturing equipment throughQualificationPeriodic reviewChange controlResponsible for execution, planning, coordination and follow-up of qualification activitiesSupport the development of a harmonized qualification approach/strategy; write and implement qualification related:SOP'sWITemplates and toolsMaintain a current knowledge of international regulation, guidelines, policies and new evolutions related to Qualification & Validation through courses, conferences, seminars, internal and external benchmarking and literature. Implement this knowledge to maintain and improve the level of qualification, validation (incl part 11).Spokesperson during internal and external audits for qualification/validation of specific manufacturing equipment, systems and QC equipment.Profile requirementsMaster in engineering, pharmacist, or similar by experience and/or training;Preferably 3-5 years (or more) relevant experience (in pharmaceutical, medical devices, diagnostics industry or other highly regulated manufacturing environment);Good technical writing skills (protocols, reports, standard operating procedures, transfer documentation, test methods) and good documentation practices;Analytical, process oriented mindset, flexible, self-organized;Affinity for technical aspect of manufacturing assets and ability to understand how things work;You can listen and separate the essence from noise, understand how to communicate to reach results and know when you need support in doing so;Assets:Knowledge of GDPKnowledge of ISO 13485 and 21 CFR 820Knowledge of PCRExperience with diagnostic systemsExperience with IVD manufacturing processesExperience with regulatory audits (FAGG, FDA or other national agencies)Planning & organization – Plans and organizes own work(load) in an effective way by setting priorities and meeting deadlinesAdapting to change – accepts and implements change and adapts, even in difficult situations.Resilience – Continues to perform effectively under time pressure and in the face of disappointment, adversity and oppositionCommunicating & influencing – Communicates with clarity: speaks and writes clearly and to-the-point; active listenerAnalytical thinking – Gathers information from varied sources, analyzes data in a critical way using common sense and logical thinkingPC Skills: MS Office (Word, Excel, PowerPoint, Outlook)Legislation and regulation:Familiar with concepts, legislation and requirements related to qualification and validation of products, processes, equipment and systems, including Part 11 and cGMP manufacturingLanguages:Good knowledge of English, both written and spoken is requiredKnowledge of Dutch is required.Our offeringWe offer you an exciting job in a fast growing international and innovative environment where you can work with top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team. You will have freedom to shape your work and shape your job where you deem it necessary: we value your input. Of course we offer you an appropriate compensation package which includes a Flexible Income Plan.