The Qualification Engineer is responsible for performing qualification and maintaining the qualified state of operational equipment, systems, Utilities, facilities and HVAC.
Develop a harmonized approach / strategy for qualification for Cartridge manufacturing;
Implement and enforce this approach through SOP’s (Standard Operation procedures) and Work instructions;
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);
Responsibility for planning, coordination, execution and follow-up of qualification activities;
Contribution to maintaining and periodically, evaluating the qualification / validation / part 11 status of equipment, systems, products and processes;
Spokesperson during internal and external audits for qualification / validation of Operational equipment (CAR), systems, products and processes and QC equipment.
Master or Bachelor in a relevant area, e.g Pharmacist, bio-engineering or you have achieved a similar level by experience;
Preferably 10 years or more relevant experience in the pharmaceutical, medical devices or diagnostics industry;
Experience with IVD manufacturing processes, preferably in the field of nucleid acid related products (Biochemical processes) is an asset;
Applied knowledge of qualification and cartridge manufacturing processes;
Excellent technical writing (protocols, reports, standard operating procedures, transfer documentation, test methods) and good documentation practices;
Legislation and regulation : ISO 13485 and CFR 820 knowledge;Familiar with concepts, legislation and requirements related to qualification and validation of products, processes, equipment and systems, including Part 11 and cGMP manufacturing;
Planning & organization Planning & organization : plans and organizes own work(load) in an effective way by setting priorities and meeting deadlines;
Adaptability to change 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;
Languages : Good knowledge of English, both written and spoken is required;Knowledge of Dutch is a major asset;
PC skills : MS Office
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.