Who we are
Based in Brussels, Belgatech is an independent Belgian company dedicated to engineering and new technology services. For more than 10 years, we support with passion the innovation and the performance of our partners, and provide to our consultants a variety of intellectual and industrial challenges.
For one of our partners and support the validation team, we are currently looking for an CSV Engineer.
What you can expect
As an CSV Engineer, you will ensure Computerized Systems are validated and that all external and internal validation requirements are met.
You will also ensure that validated Computerized Systems remain validated throughout their life cycle.
Your main responsabilities :
- Review and improve Computerized System Validation (CSV) documents (SOPs & tempates) and ensures adherence to internal and external guidelines
- Be the QA authority in the assigned area of responsibility
- Drive adherence to computer quality & compliance policies and guidelines
- Write documentation, reports and protocols
- Be involved in the creation and approval of major documents like validation plans and reports
- Ensure QA requirements for IT systems are covered
- Share expertise and knowledge to provide input to project teams and global functions
- Support, communicate and follow-up on key Quality issues related to Computer Compliance
- You have an engineering degree or a specialized Master in Industrial Informatics, Pharmaceutical Sciences or equivalent
- You have an experience in Computer System Validation and in qualification (IQOQPQ)
- You have knowledge of automated systems, data bases, servers, software…
- GMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11…)
- You know validation practices and guidelines (life cycle approach, ICH, ASTM E2500…)
- You have a good team spirit and you are an autonomous, rigorous, structured and systematic person
- French or Dutch and English speaking
Your reasons to join us
- We offer you a challenging job in an autonomous and growing Belgian tech companyfocused on engineering services.
- We attach great importance to solidarity, engagement and performance. Quality for our customer and growing employees are our top priority.
- We are committed to helping you achieve your potential, to accompany you in your personal growth and through career opportunities.
- We offer an attractive salary with various fringe benefits (package)
- We are eager to getting to know you and the opportunities we could be taking on together