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.
Responsible for execution, planning, coordination and follow-up of qualification activities
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. Spokesperson during internal and external audits for qualification/validation of specific manufacturing equipment, systems and QC equipment.
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;
Planning & organization – Plans and organizes own work(load) in an effective way by setting priorities and meeting deadlines
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)
Languages:
Good knowledge of English, both written and spoken is required
Knowledge of Dutch is required.
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.