Poslané v: Inžinierstvo v New Jersey | Posted: |
SunIRef:Manu Publication date 9 April 2021 Location Mechelen Country Belgium Functional area Production and technical operations Function type Full-time Contract type Employee Experience required Preferably 5-10 years (or more) relevant experience (in pharmaceutical, medical devices, diagnostics industry or other highly regulated manufacturing environment). Education Master in engineering, pharmacist, or similar by experience. Qualification Engineer The Qualification Engineer II is part of a 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; Preferably 5-10 years (or more) relevant experience (in pharmaceutical, medical devices, diagnostics industry or other highly regulated manufacturing environment); Good technical writing (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 - Time & priority management: plans activities effectively with respect for priorities and 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 persuasion: presents, explains and defends a complex message in a clear and concise way and persuades different stakeholders; Analytical thinking - Conducts ongoing in-depth analysis to anticipate potential problems and guides others in complex issues; 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; PC skills: MS Office (Word, Excel, PowerPoint, Outlook); Languages: Good knowledge of English, both written and spoken is required; Knowledge of Dutch is an asset. Our offering We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry. You can be part of a very dynamic, young and growing team in a highly innovative environment. You will have freedom to shape your work and shape your job. Your input is highly appreciated. Of course we offer you a fitting compensation package.