Qualification Engineer

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.