Qualification Engineer
il y a 4 semaines
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. Accountabilities Qualification and validation Equipment qualification Computer system and automation validation Maintain the qualified status of manufacturing equipment through Qualification Periodic review Change control Responsible for execution, planning, coordination and follow-up of qualification activities Support the development of a harmonized qualification approach/strategy; write and implement qualification related: SOP’s WI Templates and tools Maintain 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 requirements Master 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 GDP Knowledge of ISO 13485 and 21 CFR 820 Knowledge of PCR Experience with diagnostic systems Experience with IVD manufacturing processes Experience 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 deadlines Adapting 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 opposition Communicating & influencing – Communicates with clarity: speaks and writes clearly and to-the-point; active listener Analytical thinking – Gathers information from varied sources, analyzes data in a critical way using common sense and logical thinking PC 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 manufacturing Languages: Good knowledge of English, both written and spoken is required Knowledge of Dutch is required. Our offering We 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.
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Qualification Engineer
il y a 4 jours
Mechelen, Belgique Biocartis Temps pleinThe 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...
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Field Measurement Engineer
il y a 3 semaines
Mechelen, Belgique Commsquare Temps pleinField Measurement Engineer (ref code: FME_12_25)We are currently looking to expand our onsite Measurements Support Operations team based in Mechelen, Belgium, with a Field Measurement Engineer. It's a fulltime temporary position until December 2026.Main ResponsibilitiesPerform field measurements of mobile networks;Mainly while driving; but also, in trains...
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Field Measurement Engineer
il y a 3 semaines
Mechelen, Belgique Commsquare Temps pleinField Measurement Engineer (ref code: FME_12_25)We are currently looking to expand our onsite Measurements Support Operations team based in Mechelen, Belgium, with a Field Measurement Engineer. It's a fulltime temporary position until December 2026.Main ResponsibilitiesPerform field measurements of mobile networks;Mainly while driving; but also, in trains...
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Field Measurement Engineer
il y a 3 semaines
Mechelen, Belgique Commsquare Temps pleinField Measurement Engineer (ref code: FME_12_25) We are currently looking to expand our onsite Measurements Support Operations team based in Mechelen, Belgium, with a Field Measurement Engineer. It's a fulltime temporary position until December 2026. Main Responsibilities Perform field measurements of mobile networks; Mainly while driving; but also, in...
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Junior Measurement Support Engineer
il y a 3 semaines
Mechelen, Belgique Commsquare Temps pleinJunior Measurement Support Engineer (ref code: MSE_12_25) We are currently looking to expand our onsite Measurements Support Operations team based in Mechelen, Belgium, with a Junior Measurement Support Engineer. Main Responsibilities Configure, operate, upgrade, troubleshoot & maintain the Rohde & Schwarz/SwissQual measurement equipment or equipment...
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Junior Measurement Support Engineer
il y a 3 semaines
Mechelen, Belgique Commsquare Temps pleinJunior Measurement Support Engineer (ref code: MSE_12_25)We are currently looking to expand our onsite Measurements Support Operations team based in Mechelen, Belgium, with a Junior Measurement Support Engineer.Main ResponsibilitiesConfigure, operate, upgrade, troubleshoot & maintain the Rohde & Schwarz/SwissQual measurement equipment or equipment provided...
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Junior Measurement Support Engineer
il y a 3 semaines
Mechelen, Belgique Commsquare Temps pleinJunior Measurement Support Engineer (ref code: MSE_12_25)We are currently looking to expand our onsite Measurements Support Operations team based in Mechelen, Belgium, with a Junior Measurement Support Engineer.Main ResponsibilitiesConfigure, operate, upgrade, troubleshoot & maintain the Rohde & Schwarz/SwissQual measurement equipment or equipment provided...
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Process Engineer
il y a 4 semaines
Mechelen, Belgique Biocartis Temps pleinAs Process Engineer – Liquid Specialist at Biocartis, you are responsible for all liquid-related manufacturing processes within our state-of-the-art, highly automated production environments. This includes the preparation of Spots Solutions, Buffers and Reagent, as well as the dispensing and drying operations that are critical to our final product: the...
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Process Engineer
il y a 4 semaines
Mechelen, Belgique Biocartis Temps pleinAs Process Engineer – Liquid Specialist at Biocartis, you are responsible for all liquid-related manufacturing processes within our state-of-the-art, highly automated production environments. This includes the preparation of Spots Solutions, Buffers and Reagent, as well as the dispensing and drying operations that are critical to our final product: the...
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Process Engineer
il y a 4 semaines
Mechelen, Belgique Biocartis Temps pleinAs Process Engineer – Liquid Specialist at Biocartis, you are responsible for all liquid-related manufacturing processes within our state-of-the-art, highly automated production environments. This includes the preparation of Spots Solutions, Buffers and Reagent, as well as the dispensing and drying operations that are critical to our final product: the...
