Our client is a fast growing company active in various Life Science Industries like Pharmaceutical, Biotechnology, Medical Devices, with expertise in Qualification & Validation, Quality Assurance, Consulting, Design Engineering and Construction Management.
With 20 employees/freelances and many clients in Belgium, the company is now looking for an experienced Computerised System Validation Engineer (Freelance or Employee) for pharmaceutical projects in Belgium with very occasional travels abroad (mainly in BeNeLux and France, Germany and Switzerland). This position is also open to high potential graduated and Junior Engineers.
Do you like working in a small business with a family ambiance?
Are you ready to contribute to their continued growth?
Do you have an entrepreneurial mindset and are you passionate about working in Life Science industries?
We love meeting smart and forward-thinking talents, so don’t hold back!
Your next challenge and responsibilities
As one of our CSV Engineers, you will
1. Have a knowledge of current Industry standards, regulatory requirements and Authority expectations regarding CSV
2. Develop project specific CSV approach and methodology
3. Prepare project CSV deliverables: User Requirement Specifications Risk and Impact Analysis/Assessment (Process, Business, EHS, Regulatory) Validation Master Plan (VMP) Design Review/Qualification Test Matrices FAT, SAT, Commissioning, IQ, OQ, PQ protocols and reports
4. Support in project schedule for CSV activities
5. Organise, execute and document CSV testing
6. Support during system/installation start-up in function of CSV test activities
7. Set up and follow up of Project documentation System and Management
8. Work in close collaboration with Project, Engineering and CQV Management
You could be our ideal colleague if
9. You hold a (Professional) Bachelor or a Master’s degree (or equivalent by experience), ideally in automation-regulation, Robotics, IT or relevant other expertise
10. You have a significant (or a first) experience in Life Sciences industries and industrial automation processes, ideally min. 3 years in CSV
11. You have excellent communication skills in English and French OR in English and Dutch (written and spoken)
12. You have an enhanced knowledge of current Industry Standards, Regulatory requirements and Authority expectations (Eudralex, FDA, PICS, ICH, ISO, ASTME2500 …)
13. You have a good Comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry
14. You know the latest developments in the C&Q field and relevant legislation and industry standards (cGMP).
15. Technical expertise in engineering, electricity or automation
16. You have a field experience with: Scada, supervision and computerized system Experience in IT regulation Experience in Computerised System Validation Familiar with IT/IS systems
17. You are structured, conscientious and a precise fast-learner
18. You are a real team player who can also work independently
19. You are ready to travel and you are flexible on schedules and duties
20. You are resourceful with a CAN DO mentality who can think proactively
REM: Only short-listed and Europe-based candidates will be invited for an interview, thanks for your understanding.
We offer you
Besides an exciting flexible environment, a unique chance to participate in challenging and innovative projects and interaction with inspiring colleagues who have a professional attitude and attach considerable importance to teamwork; we stand for
21. A challenging position: Freelance or Employee
22. A full time contract 40hr/week
23. Location: Flexible depending to clients’ locations
24. A challenging job in a dynamic and knowledge-sharing network company
25. The freedom to develop yourself in line with your ambition
26. A great autonomy in your role, an excellent working atmosphere within a great team of Experts in their domain
27. For employees: a competitive salary, 32 annual days off and other benefits including a company car, fuel card, lunch vouchers, eco vouchers, pension plan, phone subscription
Would you like to work for a small company with a top level service?
We are looking forward to meeting you soon.
Your application
We’re looking for motivated and passionate individuals who love to build things and solve problems.
If this is you, please apply here or address your application, CV and a short motivation text, to us:
Mrs. Gwendoline de Robiano with Reference « Permanent/Freelance CSV Engineer »
REM: Only short-listed and Europe-based candidates will be invited for an interview, thanks for your understanding.
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