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.