At Assystem Care, we embrace your most complex challenges and anticipate new regulatory and technology paradigms in the life science industry. Combining compliance & performance expertise with engineering, we break silos to optimize the time-to-market. We take care of your industrial processes from strategy to operations, so that you can focus on your patients and your core business. This is our way to contribute to transforming the Life sciences industry.
Our unique advisory offer integrates end-to-end engineering, quality and performance management throughout your whole industrial life cycle, with a transverse vision of systems engineering : from conception & engineering to batch release and operations optimization. Starting from your challenges, our team of experts develops the customized solutions you need based on our methodologies and our own first-of-a-kind smart tools.
In practice, to ensure the success of your project, our experts commit on results and duration with your team, focusing on 3 core axes:
- Compliance & Performance of your operations, supported by continuous improvement and remediations projects via proprietary approaches & technical expertise.
- Engineering services & project management, using best-in-class risk management techniques suitable of your new and revamping industrial projects from design to validation
- Digital transformation, supported by data science, cybersecurity and knowledge management to secure your data and extract the needed insights for your business growth.
Our capability to integrate any solution and our systems engineering approach enable us to combine all these axes each time it is relevant.
To ensure the development of our activities, we are looking for a Qualification & Validation Engineer.
He or she will be in charge of :
Equipment Qualification :
- Commissioning and qualification of equipment (FAT / SAT)
- Participate in drafting risk analyses and criticality analyses
- Write the qualification master plan's methodology and strategy to deploy to the system concerned
- Write and execute IQ, OQ and PQ protocols
- Follow up non-conformities and execute required corrective actions
- Write qualification Reports
Validation Processes :
- Write the validation master plan’s methodology and strategy to deploy to the system concerned.
- Write and execute validation protocols in collaboration with production, project management, and engineering teams
- Write validation reports
Your profile :
- Master degree in Pharmacy or Process Engineering (chemistry, biotechnology, materials science), Electro Mechanics or System Engineering (programming)
- First experience in pharmaceutical sector
- Very good knowledge of aseptic environments, as well as GMP and CFR
- Knowledge of production facilities (manufacturing and packaging) for dry forms, liquid, sterile, and pastes
- Knowledge of Utility Equipment: cleaning machines, CIP / SIP, steam generators, water loops, local utilities, HVAC
- You are fluent in Dutch or French and have a good knowledge of technical English
- You are independent, rigorous, and organised, with good listening and communication skills.
Our offer :
- A salary in line with your experience
- A competitive package of extra legal benefits (car, fuel card, insurance, meal vouchers, entertainment expenses, ...)
- Career opportunities both in Belgium and abroad
- Clear objectives and challenges!
- A people focused and motivating work environment
It is up to you to create your own career within Assystem, with your ideas and your personality. No pathway is pre-destined; you follow the one that suits you best.